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Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

NCT00511342 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-02-09

Study results available
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Summary

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Conditions

  • Contraception

Interventions

DRUG

NOMAC-E2

Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

DRUG

LNG-EE

Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

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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 NCT00511342 on ClinicalTrials.gov