MedTrace Logo

A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

NCT01291004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-12-08

No results posted yet for this study

Summary

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Conditions

  • Follicle Development
  • Ovarian Follicle
  • Follicle Count
  • Follicle Size
  • Oral Contraceptive

Interventions

DRUG

Desogestrel/ethinyl estradiol and ethinyl estradiol

Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet

DRUG

28-day drospirenone oral contraceptive

Drospirenone/ethinyl estradiol 0.3/0.02 mg

DRUG

28-day levonorgestrel oral contraceptive

Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Women's Health Research Protocol Chair · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01291004 on ClinicalTrials.gov