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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR NOMEGESTROL ACETATE

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Clinical Trials for Nomegestrol acetate

Trial ID Title Status Sponsor Phase Summary
NCT00127075 POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis Unknown status Hospices Civils de Lyon Phase 3 Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery. It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.
NCT00413062 Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722) Completed Merck Sharp & Dohme Corp. Phase 3 The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
NCT00511199 Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724) Completed Merck Sharp & Dohme Corp. Phase 3 The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
NCT00511433 Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723) Completed Merck Sharp & Dohme Corp. Phase 3 The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
NCT00711607 A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Con Completed CRS Mannheim GmbH Phase 1 The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Nomegestrol acetate

Condition Name

Condition Name for
Intervention Trials
Contraception 7
Healthy Postmenopausal Females 1
Healthy 1
Suppression of Ovulation 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Dysmenorrhea 1
Sclerosis 1
Recurrence 1
Thrombophilia 1
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Clinical Trial Locations for Nomegestrol acetate

Trials by Country

Trials by Country for
Location Trials
Australia 1
France 1
Thailand 1
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Clinical Trial Progress for Nomegestrol acetate

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 8
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for Nomegestrol acetate

Sponsor Name

Sponsor Name for
Sponsor Trials
Merck Sharp & Dohme Corp. 10
Mahidol University 2
Theramex 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 12
Other 6
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