A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
NCT ID: NCT01291004
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
206 participants
INTERVENTIONAL
2011-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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28-day Desogestrel Oral Contraceptive
Desogestrel/ethinyl estradiol and ethinyl estradiol
Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
28-day Drospirenone Oral Contraceptive
28-day drospirenone oral contraceptive
Drospirenone/ethinyl estradiol 0.3/0.02 mg
28-day Levonorgestrel Oral Contraceptive
28-day levonorgestrel oral contraceptive
Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
Interventions
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Desogestrel/ethinyl estradiol and ethinyl estradiol
Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
28-day drospirenone oral contraceptive
Drospirenone/ethinyl estradiol 0.3/0.02 mg
28-day levonorgestrel oral contraceptive
Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
* Regular spontaneous menstrual cycle
* Others as dictated by Food and Drug Administration (FDA)-approved protocol
Exclusion Criteria
* Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
* Migraine headaches with focal, neurological symptoms
* Others as dictated by FDA-approved protocol
18 Years
35 Years
FEMALE
Yes
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Women's Health Research Protocol Chair
Role: STUDY_CHAIR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 10119
Philadelphia, Pennsylvania, United States
Teva Investigational Site 10118
Seattle, Washington, United States
Countries
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Other Identifiers
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DSG-OI-101
Identifier Type: -
Identifier Source: org_study_id