A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 28-day Desogestrel Oral Contraceptive
|
Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
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Active Comparator: 28-day Drospirenone Oral Contraceptive
|
Drug: 28-day drospirenone oral contraceptive
Drospirenone/ethinyl estradiol 0.3/0.02 mg
|
Active Comparator: 28-day Levonorgestrel Oral Contraceptive
|
Drug: 28-day levonorgestrel oral contraceptive
Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
|
Outcome Measures
Primary Outcome Measures
- Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [16 weeks]
- Change in serum Estradiol level from baseline to week 16. [16 weeks]
- Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [16 weeks]
- Change in serum Progesterone level from baseline to week 20. [20 weeks]
Secondary Outcome Measures
- Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [15 weeks]
- Change from baseline to week 15 in D-dimer. [15 weeks]
- Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [15 weeks]
- Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [15 weeks]
- Change from baseline to week 15 in Fibrinogen. [15 weeks]
- Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. [15 weeks]
- Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [15 weeks]
- Change from baseline to week 15 in Antithrombin. [15 weeks]
- Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [15 weeks]
- Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [15 weeks]
- Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [15 weeks]
- Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [15 weeks]
- Return to ovulation rate at week 20. [Week 20]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Premenopausal, non-pregnant, non-lactating women age 18-35 years old
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Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
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Regular spontaneous menstrual cycle
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Others as dictated by Food and Drug Administration (FDA)-approved protocol
Exclusion Criteria:
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Any condition which contraindicates the use of combination oral contraceptives
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Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
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Migraine headaches with focal, neurological symptoms
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Others as dictated by FDA-approved protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Teva Investigational Site 10119 | Philadelphia | Pennsylvania | United States | 19114 |
2 | Teva Investigational Site 10118 | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
- Study Chair: Teva Women's Health Research Protocol Chair, Teva Branded Pharmaceutical Products R&D, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DSG-OI-101