Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol (NCT01361958) | Clinical Trial Compass
CompletedPhase 2
Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol
38 participantsStarted 1997-02
Plain-language summary
The aim of the present study was to evaluate the ability of several doses of NOMAC in combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal women.
The study was also designed to check whether the combined administration of E2 and NOMAC at the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when it is given alone.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* Female premenopausal healthy volunteers having given their informed written consent at the first selection visit,
* Registered with Social Security in agreement with the French Law on biomedical research on volunteers,
* Sufficiently co-operative to meet the needs of the study,
* Accepting not to become pregnant during the trial,
* Accepting the use of condoms as the single authorized contraceptive means during the trial,
* With a diurnal and regular job or activity,
* Aged 18 to 35 years old inclusive,
* Non-smokers or current smokers of less than 10 cigarettes/day,
* With normal eating habits,
* With a body mass index between 17 and 27 inclusive,
Exclusion Criteria:
* Participation in another clinical trial,
* Blood donation in the three months prior to Visit V1 or intention to donate blood during the trial or within the three months following the trial completion,
* Virgins, because of the gynecological examination,
* Subjects who were within the exclusion period in the Healthy Volunteers National Register of the French Ministry of Health,
* Forfeiture of freedom by administrative or legal award or under guardianship,
* No possible contact in case of emergency,
* Strenuous physical activity planned during the trial. Concerning the gynecological status and examination
* History of major medical, psychiatric illness or surgery,
* Any acute or chronic systemic disease or disorder,
* History of hypersensitivity to at least one drug (abnormal drug react…