drugset / Trial / NCT01361958

Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol

NCT01361958

Phase 2 Completed 38 enrolled Theramex
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
1997-02
Primary completion
1997-11
Completion
1998-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Nomegestrol Acetate Small molecule 0.625 mg
Subject Nomegestrol Acetate Small molecule 1.25 mg
Subject Nomegestrol Acetate Small molecule 2.5 mg

Indications