Clinical Trials Directory

Trials / Completed

CompletedNCT01361958

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Theramex · Industry
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGNOMAC

Timeline

Start date
1997-02-01
Primary completion
1997-11-01
Completion
1998-09-01
First posted
2011-05-27
Last updated
2011-05-27

Source: ClinicalTrials.gov record NCT01361958. Inclusion in this directory is not an endorsement.