dehydroepiandrosterone has been researched along with Vulvar Diseases in 11 studies
Dehydroepiandrosterone: A major C19 steroid produced by the ADRENAL CORTEX. It is also produced in small quantities in the TESTIS and the OVARY. Dehydroepiandrosterone (DHEA) can be converted to TESTOSTERONE; ANDROSTENEDIONE; ESTRADIOL; and ESTRONE. Most of DHEA is sulfated (DEHYDROEPIANDROSTERONE SULFATE) before secretion.
dehydroepiandrosterone : An androstanoid that is androst-5-ene substituted by a beta-hydroxy group at position 3 and an oxo group at position 17. It is a naturally occurring steroid hormone produced by the adrenal glands.
Vulvar Diseases: Pathological processes of the VULVA.
| Excerpt | Relevance | Reference |
|---|---|---|
| "The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM)." | 9.22 | Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. ( Archer, DF; Balser, J; Beauregard, A; Côté, I; Frenette, L; Koltun, W; Labrie, F; Lavoie, L; Martel, C; Montesino, M; Moyneur, É; Parent, J; Portman, D; Vachon, A; Vaillancourt, M; Young, D, 2016) |
| "5 mg) dehydroepiandrosterone (DHEA, prasterone) for 12 weeks has shown clinically and statistically significant effects on moderate to severe (MS) dyspareunia as the most bothersome symptom (MBS), the present study analyzes the effect of a reduced dosing regimen on MBS vaginal dryness." | 9.20 | Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. ( Archer, DF; Ayotte, N; Balser, J; Bouchard, C; Cooper, TA; Côté, I; Elfassi, É; Grainger, DA; Koltun, W; Labrie, C; Labrie, F; Lavoie, L; Martel, C; Martens, M; Portman, DJ; Waldbaum, AS, 2015) |
| "The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM)." | 5.22 | Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. ( Archer, DF; Balser, J; Beauregard, A; Côté, I; Frenette, L; Koltun, W; Labrie, F; Lavoie, L; Martel, C; Montesino, M; Moyneur, É; Parent, J; Portman, D; Vachon, A; Vaillancourt, M; Young, D, 2016) |
| "5 mg) dehydroepiandrosterone (DHEA, prasterone) for 12 weeks has shown clinically and statistically significant effects on moderate to severe (MS) dyspareunia as the most bothersome symptom (MBS), the present study analyzes the effect of a reduced dosing regimen on MBS vaginal dryness." | 5.20 | Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. ( Archer, DF; Ayotte, N; Balser, J; Bouchard, C; Cooper, TA; Côté, I; Elfassi, É; Grainger, DA; Koltun, W; Labrie, C; Labrie, F; Lavoie, L; Martel, C; Martens, M; Portman, DJ; Waldbaum, AS, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 9 (81.82) | 24.3611 |
| 2020's | 2 (18.18) | 2.80 |
| Authors | Studies |
|---|---|
| Gajarawala, SN | 1 |
| Wood, TA | 1 |
| Stanton, AP | 1 |
| Wang, J | 1 |
| Wang, L | 1 |
| Pérez-López, FR | 1 |
| Phillips, N | 1 |
| Vieira-Baptista, P | 1 |
| Cohen-Sacher, B | 1 |
| Fialho, SCAV | 1 |
| Stockdale, CK | 1 |
| Labrie, F | 5 |
| Archer, DF | 4 |
| Martel, C | 5 |
| Vaillancourt, M | 2 |
| Montesino, M | 2 |
| Domoney, C | 1 |
| Bouchard, C | 2 |
| Portman, DJ | 2 |
| Koltun, W | 3 |
| Elfassi, É | 1 |
| Grainger, DA | 1 |
| Ayotte, N | 2 |
| Cooper, TA | 1 |
| Martens, M | 1 |
| Waldbaum, AS | 2 |
| Labrie, C | 2 |
| Côté, I | 3 |
| Lavoie, L | 3 |
| Balser, J | 3 |
| Girard, G | 1 |
| Gallagher, JC | 1 |
| Cusan, L | 1 |
| Baron, M | 1 |
| Blouin, F | 1 |
| Beauregard, A | 2 |
| Moyneur, É | 2 |
| Vachon, A | 1 |
| Young, D | 1 |
| Frenette, L | 1 |
| Portman, D | 1 |
| Parent, J | 1 |
| Gandhi, J | 1 |
| Chen, A | 1 |
| Dagur, G | 1 |
| Suh, Y | 1 |
| Smith, N | 1 |
| Cali, B | 1 |
| Khan, SA | 1 |
| Bélanger, A | 1 |
| Pelletier, G | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Open-Label Vulvoscopy Photography Study of Changes in Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Administration of 6.5 Mg Vaginal Prasterone in Menopausal Women With Moderate to Severe Dyspareunia[NCT03568604] | Phase 4 | 18 participants (Actual) | Interventional | 2018-08-07 | Completed | ||
| Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)[NCT03740945] | Phase 3 | 0 participants (Actual) | Interventional | 2018-11-06 | Withdrawn (stopped due to Business decision to not perform this study.) | ||
| [NCT01358760] | Phase 3 | 450 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| DHEA Against Vaginal Atrophy - Safety Study of 12 Months[NCT01256671] | Phase 3 | 530 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| A Randomized, Double-blind, Placebo-controlled Trial on the Preventive Effect of Intravaginal Prasterone (DHEA, Intrarosa®) on Recurrent Urinary Tract Infections in Women With Genitourinary Syndrome of Menopause[NCT03854396] | Phase 3 | 0 participants (Actual) | Interventional | 2020-05-31 | Withdrawn (stopped due to due to termination of ISR by PI with agreement by grant sponsor) | ||
| A Review on the Clinical Outcome of Chinese Women With Moderate to Severe Symptoms of Genitourinary Syndrome of Menopause (GSM) Treated With Vaginal Dehydroepiandrosterone (DHEA)[NCT05434351] | 4 participants (Actual) | Observational | 2022-08-01 | Terminated (stopped due to inadequate sample and only few patients were prescribed with vaginal DHEA) | |||
| A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy[NCT03782480] | Phase 3 | 40 participants (Anticipated) | Interventional | 2019-03-02 | Recruiting | ||
| [NCT02013544] | Phase 3 | 558 participants (Actual) | Interventional | 2014-02-28 | Completed | ||
| Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause[NCT05483634] | 40 participants (Anticipated) | Observational | 2022-10-28 | Not yet recruiting | |||
| Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.[NCT05585476] | 98 participants (Anticipated) | Interventional | 2022-12-31 | Not yet recruiting | |||
| Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial[NCT05627791] | Phase 2/Phase 3 | 6 participants (Actual) | Interventional | 2022-11-30 | Terminated (stopped due to Unable to recuit participant number in time.) | ||
| Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.[NCT04487392] | Phase 2 | 0 participants (Actual) | Interventional | 2020-12-15 | Withdrawn (stopped due to The student do not start the study) | ||
| To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles[NCT05471453] | 90 participants (Anticipated) | Interventional | 2022-03-02 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | percentage of parabasal cells (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 56.74 | 39.23 | -17.51 |
| 0.50% DHEA | 59.54 | 33.02 | -26.52 |
| Placebo | 60.66 | 62.22 | 1.56 |
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | percentage of superficial cells (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 1.12 | 3.43 | 2.31 |
| 0.50% DHEA | 0.93 | 3.58 | 2.66 |
| Placebo | 0.97 | 1.80 | 0.83 |
The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.58 | 1.48 | -1.10 |
| 0.50% DHEA | 2.60 | 1.54 | -1.06 |
| Placebo | 2.56 | 1.78 | -0.78 |
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.37 | 1.10 | -1.28 |
| 0.50% DHEA | 2.35 | 1.13 | -1.22 |
| Placebo | 2.38 | 1.27 | -1.12 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.60 | 2.16 | -0.45 |
| 0.50% DHEA | 2.65 | 2.12 | -0.53 |
| Placebo | 2.66 | 2.31 | -0.35 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.19 | 1.74 | -0.46 |
| 0.50% DHEA | 2.19 | 1.69 | -0.50 |
| Placebo | 2.32 | 1.94 | -0.38 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.66 | 2.25 | -0.40 |
| 0.50% DHEA | 2.72 | 2.16 | -0.56 |
| Placebo | 2.78 | 2.40 | -0.38 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 2.55 | 2.07 | -0.48 |
| 0.50% DHEA | 2.55 | 2.07 | -0.48 |
| Placebo | 2.71 | 2.33 | -0.38 |
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT01358760)
Timeframe: Baseline and Week 12
| Intervention | pH units (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.25% DHEA | 6.27 | 5.69 | -0.58 |
| 0.50% DHEA | 6.29 | 5.67 | -0.62 |
| Placebo | 6.34 | 6.06 | -0.28 |
The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup MS | Week 52: Subgroup MS | Change from Baseline: Subgroup MS | Baseline: Subgroup MBS/MS | Week 52: Subgroup MBS/MS | Change from Baseline: Subgroup MBS/MS | |
| 0.50% DHEA | 2.53 | 0.85 | -1.68 | 2.57 | 0.87 | -1.69 |
The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup MS | Week 52: Subgroup MS | Change from Baseline: Subgroup MS | Baseline: Subgroup MBS/MS | Week 52: Subgroup MBS/MS | Change from Baseline: Subgroup MBS/MS | |
| 0.50% DHEA | 2.10 | 0.60 | -1.50 | 2.13 | 0.74 | -1.39 |
The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup MS | Week 52: Subgroup MS | Change from Baseline: Subgroup MS | Baseline: Subgroup MBS/MS | Week 52: Subgroup MBS/MS | Change from Baseline: Subgroup MBS/MS | |
| 0.50% DHEA | 2.22 | 0.59 | -1.63 | 2.19 | 0.67 | -1.52 |
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | percentage of parabasal cells (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup ALL | Week 52: Subgroup ALL | Change from Baseline: Subgroup ALL | Baseline: Subgroup VVA | Week 52: Subgroup VVA | Change from Baseline: Subgroup VVA | |
| 0.50% DHEA | 55.49 | 12.81 | -42.67 | 63.95 | 14.80 | -49.14 |
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | percentage of superficial cells (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup ALL | Week 52: Subgroup ALL | Change from Baseline: Subgroup ALL | Baseline: Subgroup VVA | Week 52: Subgroup VVA | Change from Baseline: Subgroup VVA | |
| 0.50% DHEA | 2.02 | 9.42 | 7.41 | 0.96 | 8.81 | 7.85 |
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | pH (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Subgroup ALL | Week 52: Subgroup ALL | Change from Baseline: Subgroup ALL | Baseline: Subgroup VVA | Week 52: Subgroup VVA | Change from Baseline: Subgroup VVA | |
| 0.50% DHEA | 6.23 | 5.09 | -1.14 | 6.40 | 5.13 | -1.27 |
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented. (NCT01256671)
Timeframe: Baseline and Week 52 (or discontinuation)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Endometrium: Atrophic/Inactive | Endometrium: No/Insufficient Tissue for Diagnosis | |
| 0.50% DHEA | 421 | 36 |
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. (NCT01256671)
Timeframe: Baseline and Week 52
| Intervention | pg/mL (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DHEA: Baseline | DHEA: Week 52 | DHEA: Change from Baseline | E2: Baseline | E2: Week 52 | E2: Change from Baseline | TESTO: Baseline | TESTO: Week 52 | TESTO: Change from Baseline | |
| 0.50% DHEA | 2071.61 | 2997.25 | 925.65 | 6.05 | 4.46 | -1.59 | 161.28 | 189.44 | 28.17 |
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | Percentage of parabasal cells (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 54.25 | 12.74 | -41.51 |
| Placebo | 51.66 | 39.68 | -11.98 |
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | Percentage of superficial cells (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 1.02 | 11.22 | 10.20 |
| Placebo | 1.04 | 2.78 | 1.75 |
The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.54 | 1.13 | -1.42 |
| Placebo | 2.56 | 1.50 | -1.06 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.75 | 2.03 | -0.73 |
| Placebo | 2.67 | 2.34 | -0.33 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.45 | 1.75 | -0.69 |
| Placebo | 2.43 | 2.06 | -0.37 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.83 | 2.09 | -0.74 |
| Placebo | 2.76 | 2.41 | -0.36 |
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.70 | 1.97 | -0.73 |
| Placebo | 2.63 | 2.24 | -0.39 |
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 2.30 | 0.86 | -1.44 |
| Placebo | 2.30 | 1.13 | -1.17 |
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. (NCT02013544)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 12 | Change from Baseline to Week 12 | |
| 0.50% Prasterone (DHEA) | 6.34 | 5.39 | -0.94 |
| Placebo | 6.32 | 6.05 | -0.27 |
6 reviews available for dehydroepiandrosterone and Vulvar Diseases
| Article | Year |
|---|---|
▼Prasterone for vulvar and vaginal atrophy.
Topics: Administration, Intravaginal; Atrophy; Dehydroepiandrosterone; Female; Humans; Pessaries; Vaginal Di | 2019 |
The therapeutic effect of dehydroepiandrosterone (DHEA) on vulvovaginal atrophy.
Topics: Animals; Atrophy; Dehydroepiandrosterone; Female; Humans; Postmenopause; Vagina; Vaginal Diseases; V | 2021 |
Management of postmenopausal vulvovaginal atrophy: recommendations of the International Society for the Study of Vulvovaginal Disease.
Topics: Administration, Intravaginal; Atrophy; Breast Neoplasms; Dehydroepiandrosterone; Estrogens; Female; | 2021 |
Treatment of vaginal atrophy.
Topics: Administration, Cutaneous; Administration, Intravaginal; Administration, Oral; Androgens; Atrophic V | 2014 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.
Topics: Atrophic Vaginitis; Dehydroepiandrosterone; Dyspareunia; Estrogen Replacement Therapy; Female; Human | 2016 |
Androgens in women are essentially made from DHEA in each peripheral tissue according to intracrinology.
Topics: Androgens; Animals; Atrophy; Dehydroepiandrosterone; Estrogens; Female; Gonadal Steroid Hormones; Hu | 2017 |
4 trials available for dehydroepiandrosterone and Vulvar Diseases
1 other study available for dehydroepiandrosterone and Vulvar Diseases
| Article | Year |
|---|---|
What is the role of dehydroepiandrosterone in gynecologic practice?
Topics: Administration, Intravaginal; Administration, Oral; Atrophy; Dehydroepiandrosterone; Dyspareunia; Fe | 2019 |