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

Phase 1

Completed

• Conditions: Follicle Development; Follicle Count; Ovarian Follicle; Follicle Size; Oral Contraceptive
• Interventions: Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol; Drug: 28-day drospirenone oral contraceptive; Drug: 28-day levonorgestrel oral contraceptive

• Registration Number: NCT01291004
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2012-03-31
• Study Completion: 2012-03-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 206

Inclusion Criteria

• Premenopausal, non-pregnant, non-lactating women age 18-35 years old
• 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

• Any condition which contraindicates the use of combination oral contraceptives
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
28-day Desogestrel Oral Contraceptive	Desogestrel/ethinyl estradiol and ethinyl estradiol	-
28-day Drospirenone Oral Contraceptive	28-day drospirenone oral contraceptive	-
28-day Levonorgestrel Oral Contraceptive	28-day levonorgestrel oral contraceptive	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Return to ovulation rate at week 20.	Week 20
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).	15 weeks
Change from baseline to week 15 in D-dimer.	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 Prothrombin fragment 1 + 2 levels.	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 Tissue Plasminogen Activator (t-PA).	15 weeks
Change from baseline to week 15 in Antithrombin.	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 Tissue Factor Pathway Inhibitor (TFPI).	15 weeks
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).	15 weeks

Trial Locations

Locations (2)

Teva Investigational Site 10119; 🇺🇸 Philadelphia, Pennsylvania, United States

Teva Investigational Site 10118; 🇺🇸 Seattle, Washington, United States