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A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

NCT01388491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2021-12-06

Study results available
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Summary

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Conditions

  • Hemostasis
  • Oral Contraceptive

Interventions

DRUG

desogestrel/ethinyl estradiol and ethinyl estradiol

DRUG

desogestrel/ethinyl estradiol

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Women's Health Research Protocol Chair · Teva Women's Health Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Germany
  • Israel
  • Italy
  • Spain

Study Locations

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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 NCT01388491 on ClinicalTrials.gov