promestriene and Atrophy

Urogenital symptoms resulting from estrogen deficiency are common problems that impair quality of life and sexuality. Potentially, one out of three postmenopausal women could benefit from a vaginal estrogen therapy, but the fear of systemic absorption limits its use. Promestriene used vaginally to relieve vaginal atrophy is a locally effective estrogen that has not shown systemic estrogenic effects. Thus, it could be a first-line option for those who necessitate a minimal or ideally no vaginal absorption, particularly in symptomatic cancer patients. There are little data available in the literature, mostly consisting of small, open-label, short duration studies, and few randomized-controlled studies. After a long-term market experience (almost 40 years), in 34 countries, and millions of pieces prescribed, the side effects were very rarely reported in pharmacovigilance data, whereas the effectiveness to relieve atrophy was good. To further improve promestriene safety, especially in estrogen-sensitive cancer patients, a very low dose is used from the beginning, starting from half or less of the usual dose, and then gradually increased till the minimum effective dose, which could further reduce its already minimal vaginal absorption.

Topics: Administration, Intravaginal; Atrophy; Clinical Trials as Topic; Estradiol; Estrogen Replacement Therapy; Female; Humans; Neoplasms; Treatment Outcome; Vagina

Hypoestrogenemia-derived urogenital symptoms after menopause manifest after some years of hormonal deficit and appear commonly in elderly, untreated women. In the urogenital tract low postmenopausal estrogen levels lead to vaginal irritation and dryness and to dyspareunia, often accompanied by other symptoms like uriesthesis, incontinence or recurrent infections. Every systemic estrogen treatment is accepted as efficient for the correction of urogenital symptoms, often even at doses lower than those necessary for the correction of vasomotor symptoms. Diverse local treatments have been proposed: estriol, promestriene and low-dose estrone or estradiol. Promestriene applied locally stimulates differentiation and maturation of vaginal mucosa and compensates local hypoestrogenic effects without marked hormonal effects outside the vagina. Vaginal application of estrone, on the other hand, has rather been proposed for systemic hormone substitution and elevated levels of estrone and estradiol observed in the plasma render this method in-appropriate in cases where strictly local effects are desired. Recently, very low doses of estradiol in a range of 7.5 micrograms/day have been proposed for the treatment of urogenital atrophy by means of a prolonged release regimen. Among the described preparations, those with strictly local (devoid of systemic) effects should be restricted to patients with contraindications for systemic substitution therapy. Local estrogen therapies are recommended for the treatment of complaints due to vulvar and vaginal atrophy. They have also been proposed by certain authors for the acceleration of the cervico-vaginal and vulvar cicatrisation after surgical interventions or postpartum. The presence of miction disorders in elderly postmenopausal women is also a point in favour of local treatment.

Topics: Administration, Intravaginal; Adult; Aged; Animals; Atrophy; Climacteric; Estradiol; Estradiol Congeners; Estrogen Replacement Therapy; Estrogens; Female; Female Urogenital Diseases; Humans; Middle Aged; Urogenital System

This study aimed to compare the efficacy of CO 2 laser, radiofrequency, and promestriene in treating genitourinary syndrome of menopause in women with breast cancer receiving adjuvant therapy and to analyze the clinical and histological findings of the vulvar vestibule.. Women with moderate-to-severe symptoms of vulvar atrophy were enrolled. The participants were evaluated according to pretreatment and posttreatment protocols using the visual analog scale and clinical assessments, which included a gynecological examination and vestibular biopsy. Participants were randomly assigned into the laser, radiofrequency, or promestriene groups. Participants in the energy treatment groups underwent three consecutive monthly outpatient vulvovaginal treatment sessions, whereas those in the control group were administered promestriene for 4 months. During a follow-up visit 30 days posttreatment, the participant global posttreatment impression of improvement was evaluated using a Likert scale.. Seventy women completed treatment. Histological vulvar atrophy was identified in four (5.7%) of the pretreatment vulvar samples. Postintervention, all histological parameters were normalized. Significant improvements in symptoms were observed, as all three groups showed a reduction in the visual analog scale score, with no statistically significant differences among them. A high level of satisfaction was reported posttreatment in all groups. No damage to the histological structure of the vulvar vestibule or relevant clinical adverse events were identified posttreatment.. Laser, radiofrequency, and promestriene delivered comparable, significant symptom improvements among women with breast cancer receiving adjuvant therapy. These treatments did not cause structural tissue damage or other clinical complications.

Topics: Atrophy; Breast Neoplasms; Cancer Survivors; Female; Humans; Lasers, Gas; Menopause; Treatment Outcome; Vagina

Vulvovaginal atrophy is frequent, can be bothersome and can impair quality of life in postmenopausal women. The main objective of this prospective, randomized study was to compare the acceptability of low-dose vaginal 17β-estradiol (estradiol) tablets and vaginal promestriene cream in postmenopausal women with moderate-to-severe symptomatic vulvovaginal atrophy.. Overall, 120 patients were randomized to receive estradiol or promestriene (. Our results support the use of vaginal low-dose estradiol tablets as compared to vaginal promestriene cream for the management of moderate-to-severe symptomatic vulvovaginal atrophy in postmenopausal women.. NCT04232813.

Topics: Administration, Intravaginal; Atrophy; Estradiol; Estrogens; Female; Humans; Postmenopause; Quality of Life; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies

In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM).. A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness.. After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05).. Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.

Topics: Atrophy; Double-Blind Method; Estradiol; Female; Humans; Menopause; Oxytocin; Pilot Projects; Postmenopause; Prospective Studies; Syndrome; Treatment Outcome; Vagina

The aim of this study was to compare the effects of fractional CO2 laser therapy, promestriene, and vaginal lubricants on genitourinary syndrome treatment and sexual function in postmenopausal women.. We performed a randomized clinical trial including 72 postmenopausal women over the age of 50 years. The women were randomized into three intervention groups to receive one of the following treatments: three sessions of intravaginal fractional CO2 laser therapy; 10 mg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone. Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI) were evaluated at baseline and after 14 weeks of therapy.. We observed an improvement in the vaginal elasticity, volume, moisture, and pH in the CO2 laser and promestriene groups. The VHI score at 14 weeks was higher in the CO2 laser group (mean score 18.68) than in the promestriene (15.11) and lubricant (10.44) groups (P < 0.001). Regarding vaginal maturation, basal cells were reduced and superficial cells were increased after treatment. This improvement was more significant in the CO2 laser group (P <0.001). The FSFI score only showed improvement in the desire and lubrication domains in the CO2 laser group. There were no differences in total FSFI score among the three treatment groups. There were no adverse effects associated with any of the treatments.. The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.

Topics: Administration, Intravaginal; Atrophy; Estradiol; Estrogens; Female; Female Urogenital Diseases; Humans; Lasers, Gas; Lubricants; Middle Aged; Postmenopause; Sexual Dysfunction, Physiological; Syndrome

Vaginal promestriene was tested in gynecological cancer patients who suffered from severe vaginal dryness and dyspareunia. This form of estrogen has a low level of vaginal absorption and proved to be effective for vaginal atrophy.. 17 patients were treated with a 10mg soft vaginal suppository daily for one month. Plasma levels of estrone sulfate (E1S), used as the marker of overall estrogenicity, were measured by liquid chromatography in combination with mass spectrometry.. Mean E1S levels changed from 533 (22-2920) to 374 (81-856) pg/ml (p=0.39).. In highly symptomatic gynecological cancer patients the level of circulating estrone sulfate was not significantly affected by vaginal promestriene treatment overall, but a wide range of levels was noted pre and post treatment in individual patients.

Topics: Adult; Aged; Atrophy; Dyspareunia; Estradiol; Estrogens; Estrone; Female; Genital Neoplasms, Female; Humans; Middle Aged; Pilot Projects; Suppositories; Vagina; Vaginal Diseases

To investigate the safety and efficacy of promestriene capsule used in the treatment of postmenopausal atrophic vaginitis.. Fifty-three women at age of 45 - 75 years (more than one year history of menopause) diagnosed with postmenopausal atrophic vaginitis were enrolled in self-control study. They all had typicalsymptoms of postmenopausal vaginitis. Promestriene was given by continuous therapy for 20 days, then maintenance therapy for for 8 weeks (1 pill two times per week used). The level of follicle stimulation hormone (FSH) and estradiol (E(2)) in serum was and thickness of endometrium were detected before and after treatment. The routine biochemical test was used as index to monitoring the safety. The vaginal mature index (VMI), the atrophic vaginitis evaluating score and vaginal healthy evaluating score were evaluated for therapeutic effect. In the mean time, adverse effect was recorded.. (1) SAFETY: during promestriene treatment, no case with adverse effect was observed. Before treatment, the mean level of FSH and E(2) was (71 +/- 3) U/L and (41 +/- 18) pmol/L, the mean thickness of endometrium was (2.4 +/- 0.9) mm. After treatment, the mean level of FSH and E(2) was (67 +/- 22) U/L and (43 +/- 37) pmol/L, the mean thickness of endometrium was (2.5 +/- 1.3) mm. No significant difference was observed (P > 0.05). (2) Therapeutic effect: VMI were 42 +/- 15 before and 54 +/- 8 after treatment. The atrophic vaginitis evaluating score were 3.4 +/- 1.7 before and 1.5 +/- 1.4 after treatment. Vaginal healthy evaluating score were 7.8 +/- 2.4 before and 12.0 +/- 2.4 after treatment. They all showed significant difference (P < 0.01). (3) Adverse effect: six cases with vaginal bleeding, 3 cases with breast nodules and 1 case with cervical polyp was observed, however, it was uncertain whether those events were associated with promestriene use.. The premestriene capsule was safe and effective in the treatment of postmenopausal atrophic vaginitis.

Topics: Administration, Intravaginal; Aged; Atrophy; Capsules; Estradiol; Female; Hormone Replacement Therapy; Humans; Middle Aged; Postmenopause; Quality of Life; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginitis

To determine whether the use of local Estrogen Replacement Therapy (ERT) affects the adequacy of colposcopic examination; to distinguish abnormal cervical smears secondary to hypoestrogenism from abnormal cervical smears due to true preneoplastic changes; and to suggest an effective management of atypical squamous cells of undeterminated significance (ASCUS) and low grade squamous intraepithelial lesion (L-SIL) in menopausal women.. Two-hundred fifty-four postmenopausal women with abnormal pap smears (L-SIL or ASCUS) underwent colposcopy and HPV DNA testing. All patients with positive colposcopy underwent punch biopsy, and all patients with positive histological findings underwent surgical treatment. Patients with negative colposcopy, both satisfactory [visible Squamo-Columnar Junction (SCJ)] and unsatisfactory, were treated with local estrogenic replacement therapy (ERT) for 3 months, and repeated colposcopy and pap smears. Patients with negative colposcopy and negative pap smears after ERT were included in a 6 months cytological and colposcopic follow-up. Patients with positive colposcopy underwent punch biopsy, if colposcopy was negative and cytology was positive, patients underwent endocervical curettage.. One-hundred ninety-five had a diagnosis of ASCUS and 59 a diagnosis of L-SIL. At the first colposcopy, 39 patients showed a lesion and had an appropriate treatment. One-hundred eighty-eight in the ASCUS group and 27 in the L-SIL group had a negative colposcopy and were treated with local ERT. At first colposcopic examination, 37 of the 215 negative colposcopies resulted satisfactory and 178 of the 215 resulted unsatisfactory. After local ERT, 130 of the 178 patients had a satisfactory follow-up colposcopy. After ERT, 25 patients of 215 with initial abnormal CVS and negative colposcopy, required appropriate treatment. After ERT, 190 patients of 215 showed negative colposcopy and at cytologic follow-up showed 23 ASCUS and 167 normal CVS.. A correct diagnosis and an efficient treatment seem to be obtained with a short-time ERT followed by a short-time cytological and colposcopic follow-up. With a single course of local ERT it may be possible to distinguish between benign CVS mimicking atrophy and true preneoplastic changes. Estrogen therapy will often cause enough ectropion of the endocervical cells so that the entire SCJ can be visualized. Moreover, it may reduce the number of endocervical curettage or loop excision or cone procedure for women with inadequate colposcopic examination.

Topics: Administration, Intravaginal; Atrophy; Colposcopy; Diagnosis, Differential; Estradiol; Estrogen Replacement Therapy; Female; Humans; Middle Aged; Papanicolaou Test; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Vagina; Vaginal Diseases; Vaginal Smears

Topical estrogen therapy is recommended for the treatment of vaginal atrophy. This study was designed to compare the uterotrophic effects of a new estrogen vaginal formulation (0.005% estriol vaginal gel) and other existing topical treatments (Ovestinon(®) and Colpotrofin(®)).. Each one of the studied formulations was administered intravaginally to groups of ovariectomized rats with cytologically confirmed vaginal atrophy. The doses were adjusted by animal weight according to human dosage. After daily treatment for 14days, the animals were sacrificed and their vaginas and uteri removed. All uteri were weighted. Uteri and vaginas were fixed for histological evaluation.. All three active formulations proved to be very effective in the cytological reversal of vaginal atrophy. However, they differ in their effects in the uteri. Ovestinon(®) and Colpotrofin(®) produced a significant increase in uterine weight, myometrial and endometrial thickness as well as histological modifications in the endometrium suggestive of estrogenic activity. Conversely, animals treated with 0.005% estriol vaginal gel, did not show significant weight increase or any other macroscopical or microcospical modifications of the uteri, an effect comparable to placebo.. There are significant differences in the uterotrophic effect of three different topical estrogen formulations as tested in a rat model of vaginal postmenopausal atrophy. While the three formulations were equally effective in reversing vaginal atrophy, only the newly developed ultra-low dose 0.005% estriol vaginal gel has proved to lack any significant estrogenic effect on the uterus.

Topics: Administration, Intravaginal; Animals; Atrophy; Endometrium; Estradiol; Estriol; Estrogens; Female; Myometrium; Organ Size; Ovariectomy; Rats; Rats, Wistar; Uterine Diseases; Uterus; Vagina; Vaginal Diseases

We report a case of hyperestrogenisation which showed itself by the presence of a haematocolpometra in an elderly lady which could be attributed to prolonged and continuous treatment with Promestriene cream. Haematocolpometra is due to intra-uterine haemorrhage (itself due to hyperplastic endometrial polyps) with vaginal stenosis caused by vaginal atrophy that existed before local treatment was started. The Pomestriene is an estrogenic substance which works locally and does not seem to cause much in the way of general effects when used for short courses. If when it is used in large doses over a prolonged period of time, however, it is necessary to look for generalised hyperestrogenisation. Further studies are needed to confirm these finding.

Topics: Administration, Topical; Aged; Aged, 80 and over; Atrophy; Drug Overdose; Estradiol; Estradiol Congeners; Female; Hematocolpos; Humans; Uterine Hemorrhage; Vagina