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A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

NCT01252186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2015-03-13

Study results available
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Summary

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Conditions

  • Hemostasis
  • Oral Contraceptive

Interventions

DRUG

91-day Levonorgestrel Oral Contraceptive

91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.

DRUG

28-day Levonorgestrel Oral Contraceptive

21 combination tablets containing 150 µg LNG/30 µg EE.

DRUG

28-day Desogestrel Oral Contraceptive

21 combination tablets containing 150 µg DSG/30 µg EE.

Sponsors & Collaborators

  • Teva Women's Health

    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
2010-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Italy

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 NCT01252186 on ClinicalTrials.gov