norethindrone acetate and Postpartum Amenorrhea studies

norethisterone acetate : A 3-oxo Delta(4)-steroid that is norethisterone in which the hydroxy group has been converted to its acetate ester.

Research Excerpts

Excerpt	Relevance	Reference
"To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids."	9.19	Long-term treatment of uterine fibroids with ulipristal acetate ☆. ( Barlow, DH; Bestel, E; Bouchard, P; Donnez, J; Donnez, O; Fauser, BC; Loumaye, E; Nouri, K; Osterloh, I; Palacios, S; Tomaszewski, J; Vázquez, F, 2014)
" The ultra-low dose of ethinyl estradiol did not impact scheduled bleeding or intensity of bleeding, but we observed a slight decline in amenorrhea and slight increase in unscheduled bleeding in obese women compared with other BMI categories."	5.22	Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. ( Archer, DF; Nakajima, ST; Pappadakis, J, 2016)
"To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids."	5.19	Long-term treatment of uterine fibroids with ulipristal acetate ☆. ( Barlow, DH; Bestel, E; Bouchard, P; Donnez, J; Donnez, O; Fauser, BC; Loumaye, E; Nouri, K; Osterloh, I; Palacios, S; Tomaszewski, J; Vázquez, F, 2014)
"The incidence and duration of vaginal bleeding were assessed throughout the study."	2.71	Reduced vaginal bleeding in postmenopausal women who receive combined norethindrone acetate and low-dose ethinyl estradiol therapy versus combined conjugated equine estrogens and medroxyprogesterone acetate therapy. ( Liu, JH; Shumel, BS; Simon, JA; Speroff, L; Symons, JP, 2003)
" Parameters like age of the patients, body mass index (BMI), dosage of the estrogen during pretreatment did not influence the results considerably."	2.70	[Amenorrhea rate after switch from sequential hormone replacement therapy to continuous combined administration of low dose estradiol and norethisterone acetate]. ( Kretschmar, S; Rakov, V; Von Holst, T, 2002)
"Amenorrhea is a clinical condition characterized by failure of menarche or by the absence of menstruation for six months in a woman with previous periodic menses."	1.31	Cyclic estrogen-progestin hormone therapy as a new therapeutic approach in the treatment of functional alterations of the hypothalamus-pituitary-ovary axis: case reports. ( Russo, P; Trimarchi, CP, 2002)
" This study shows that estrogen/progestogen treatment in standard contraceptive dosage usually leads to only moderate and non-progressive stimulation of pituitary activity in women with hyperprolactinemic amenorrhea, but occasional excessive growth of a prolactinoma can occur and treatment needs to be monitored."	1.28	The effect of combined estrogen/progestogen treatment in women with hyperprolactinemic amenorrhea. ( Fahy, UM; Foster, PA; Hartog, M; Hull, MG; Torode, HW, 1992)
"The busulfan which she was receiving at that time was stopped and amniocentesis revealed a normal karyotype."	1.27	Reversible busulfan-induced ovarian failure. ( Milwidsky, A; Rahav, G; Shalev, O, 1987)

Timeframe	Studies, this research(%)	All Research%
pre-1990	3 (21.43)	18.7374
1990's	3 (21.43)	18.2507
2000's	4 (28.57)	29.6817
2010's	2 (14.29)	24.3611
2020's	2 (14.29)	2.80

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and[NCT01156857]	Phase 3	209 participants (Actual)	Interventional	2010-07-31	Completed
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until [NCT01252069]	Phase 3	132 participants (Actual)	Interventional	2011-01-31	Completed
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol[NCT00391807]	Phase 3	1,683 participants (Actual)	Interventional	2006-11-30	Completed
A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0[NCT00184795]	Phase 3	576 participants (Actual)	Interventional	2004-05-28	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Article	Year
Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertility and sterility, 2014, Volume: 101, Issue:6 Topics: Administration, Oral; Adult; Amenorrhea; Antineoplastic Agents, Hormonal; Antineoplastic Combined Ch	2014
Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertility and sterility, 2014, Volume: 101, Issue:6 Topics: Administration, Oral; Adult; Amenorrhea; Antineoplastic Agents, Hormonal; Antineoplastic Combined Ch	2014
Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertility and sterility, 2014, Volume: 101, Issue:6 Topics: Administration, Oral; Adult; Amenorrhea; Antineoplastic Agents, Hormonal; Antineoplastic Combined Ch	2014
Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertility and sterility, 2014, Volume: 101, Issue:6 Topics: Administration, Oral; Adult; Amenorrhea; Antineoplastic Agents, Hormonal; Antineoplastic Combined Ch	2014
Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception, 2016, Volume: 93, Issue:1 Topics: Adolescent; Adult; Amenorrhea; Body Mass Index; Contraceptives, Oral, Combined; Contraceptives, Oral	2016
[Amenorrhea rate after switch from sequential hormone replacement therapy to continuous combined administration of low dose estradiol and norethisterone acetate]. Zentralblatt fur Gynakologie, 2002, Volume: 124, Issue:7 Topics: Amenorrhea; Estradiol; Estrogen Replacement Therapy; Female; Humans; Middle Aged; Norethindrone; Nor	2002
Reduced vaginal bleeding in postmenopausal women who receive combined norethindrone acetate and low-dose ethinyl estradiol therapy versus combined conjugated equine estrogens and medroxyprogesterone acetate therapy. American journal of obstetrics and gynecology, 2003, Volume: 188, Issue:1 Topics: Adult; Amenorrhea; Double-Blind Method; Estrogen Replacement Therapy; Estrogens, Conjugated (USP); E	2003
Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric : the journal of the International Menopause Society, 2008, Volume: 11, Issue:1 Topics: Adult; Aged; Amenorrhea; Contraceptives, Oral, Synthetic; Dose-Response Relationship, Drug; Double-B	2008

Article	Year
Outcomes of Menstrual Management Use in Transgender and Gender-Diverse Adolescents. Obstetrics and gynecology, 2023, 04-01, Volume: 141, Issue:4 Topics: Adolescent; Amenorrhea; Child; Contraceptive Agents, Female; Female; Hemorrhage; Humans; Infant, New	2023
Efficacy and safety of ultra-low-dose estradiol and norethisterone in postmenopausal Brazilian women. Climacteric : the journal of the International Menopause Society, 2023, Volume: 26, Issue:4 Topics: Amenorrhea; Brazil; Double-Blind Method; Estradiol; Estrogen Replacement Therapy; Female; Humans; Mi	2023
Cyclic estrogen-progestin hormone therapy as a new therapeutic approach in the treatment of functional alterations of the hypothalamus-pituitary-ovary axis: case reports. Endocrine research, 2002, Volume: 28, Issue:3 Topics: Adenoma; Adult; Amenorrhea; Drug Administration Schedule; Drug Therapy, Combination; Estradiol; Feed	2002
EFFECT OF NORETHINDRONE ACETATE UPON GONADOTROPIN-INDUCED OVARIAN FUNCTION. The Journal of clinical endocrinology and metabolism, 1965, Volume: 25 Topics: Amenorrhea; Chorionic Gonadotropin; Drug Therapy; Endometrial Hyperplasia; Estrogens; Female; Follic	1965
[Clinical experience with norethisterone acetate]. El Dia medico, 1961, Sep-21, Volume: 33 Topics: Amenorrhea; Breast Diseases; Dysmenorrhea; Female; Humans; Norethindrone; Norethindrone Acetate; Pre	1961
The effect of combined estrogen/progestogen treatment in women with hyperprolactinemic amenorrhea. Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 1992, Volume: 6, Issue:3 Topics: Adolescent; Adult; Amenorrhea; Drug Therapy, Combination; Ethinyl Estradiol; Female; Humans; Hyperpr	1992
Continuous combined conjugated equine estrogen-progestogen therapy: effects of medroxyprogesterone acetate and norethindrone acetate on bleeding patterns and endometrial histologic diagnosis. American journal of obstetrics and gynecology, 1992, Volume: 167, Issue:1 Topics: Amenorrhea; Atrophy; Drug Therapy, Combination; Endometrium; Estrogen Replacement Therapy; Female; H	1992
Bioavailability of norethindrone and menstrual pattern after insertion of norethindrone acetate implants in rhesus monkeys. Contraception, 1991, Volume: 44, Issue:3 Topics: Amenorrhea; Animals; Biological Availability; Drug Implants; Female; Macaca mulatta; Menstruation; N	1991
Reversible busulfan-induced ovarian failure. European journal of obstetrics, gynecology, and reproductive biology, 1987, Volume: 26, Issue:3 Topics: Adult; Amenorrhea; Busulfan; Estradiol; Estrogens, Conjugated (USP); Female; Follicle Stimulating Ho	1987

norethindrone acetate and Postpartum Amenorrhea

Research Excerpts

Research

Studies (14)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population

Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population

Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population

Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population

Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population

Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population

Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population

Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population

Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population

Trials

Other Studies

Authors	Studies
Schwartz, BI	1
Bear, B	1
Short, VL	1
Kazak, AE	1
Bonassi Machado, R	1
Pompei, LM	1
Nahas, EAP	1
Nahas-Neto, J	1
Costa-Paiva, LD	1
Del Debbio, SYO	1
Badalotti, M	1
Wender, MCO	1
Cruz, AM	1
Donnez, J	1
Vázquez, F	1
Tomaszewski, J	1
Nouri, K	1
Bouchard, P	1
Fauser, BC	1
Barlow, DH	1
Palacios, S	1
Donnez, O	1
Bestel, E	1
Osterloh, I	1
Loumaye, E	1
Nakajima, ST	1
Pappadakis, J	1
Archer, DF	2
Von Holst, T	1
Rakov, V	2
Kretschmar, S	1
Trimarchi, CP	1
Russo, P	1
Simon, JA	1
Liu, JH	1
Speroff, L	1
Shumel, BS	1
Symons, JP	1
TAYMOR, ML	1
RIZKALLAH, T	1
SALABER, JB	1
ARGUELLES, AE	1
Sturdee, DW	1
Lang, E	1
Fahy, UM	1
Foster, PA	1
Torode, HW	1
Hartog, M	1
Hull, MG	1
Hillard, TC	1
Siddle, NC	1
Whitehead, MI	1
Fraser, DI	1
Pryse-Davies, J	1
Jha, P	1
Murugesan, K	1
Farooq, A	1
Shalev, O	1
Rahav, G	1
Milwidsky, A	1