Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-blind, Comparative, Randomized, Single Center, Between-subject, Dose-finding Clinical Trial to Compare 4 Doses of the Combination 17beta-estradiol/Nomegestrol Acetate Administered From Day 1 to Day 21 of the Menstrual Cycle on the Inhibition of Ovulation|
|Study Start Date:||February 1997|
|Study Completion Date:||September 1998|
|Primary Completion Date:||November 1997 (Final data collection date for primary outcome measure)|
|Experimental: T1 received 0.625 mg NOMAC + 1.5 mg E2||Drug: NOMAC|
|Experimental: T2 received 1.25 mg NOMAC + 1.5 mg E2||Drug: NOMAC|
|Experimental: T3 received 2.5 mg NOMAC + 1.5 mg E2||Drug: NOMAC|
|Experimental: T4 received 2.5 mg NOMAC + Lactose||Drug: NOMAC|