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

NCT01361958 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2011-05-27

No results posted yet for this study

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

  • Suppression of Ovulation

Interventions

DRUG

NOMAC

Sponsors & Collaborators

  • Theramex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-02-28
Primary Completion
1997-11-30
Completion
1998-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361958 on ClinicalTrials.gov