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

• ClinicalTrials.gov Identifier: NCT01291004
• Recruitment Status: Completed
• First Posted: February 7, 2011
• Last Update Posted: December 8, 2021
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Teva Branded Pharmaceutical Products R&D, Inc.

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
Follicle Development; Ovarian Follicle; Follicle Count; Follicle Size; Oral Contraceptive	Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol; Drug: 28-day drospirenone oral contraceptive; Drug: 28-day levonorgestrel oral contraceptive	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins
• Actual Study Start Date: January 31, 2011
• Actual Primary Completion Date: March 31, 2012
• Actual Study Completion Date: March 31, 2012

Arms and Interventions

Arm	Intervention/treatment
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
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 :

1. Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [ Time Frame: 16 weeks ]
2. Change in serum Estradiol level from baseline to week 16. [ Time Frame: 16 weeks ]
3. Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [ Time Frame: 16 weeks ]
4. Change in serum Progesterone level from baseline to week 20. [ Time Frame: 20 weeks ]

Secondary Outcome Measures :

1. Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ]
2. Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ]
3. Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [ Time Frame: 15 weeks ]
4. Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ]
5. Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ]
6. Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. [ Time Frame: 15 weeks ]
7. Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ]
8. Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ]
9. Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ]
10. Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ]
11. Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ]
12. Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ]
13. Return to ovulation rate at week 20. [ Time Frame: Week 20 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Teva Investigational Site 10119

Philadelphia, Pennsylvania, United States, 19114

United States, Washington

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.

More Information

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT01291004
• Other Study ID Numbers: DSG-OI-101
• First Posted: February 7, 2011
• Last Update Posted: December 8, 2021
• Last Verified: December 2021

Additional relevant MeSH terms:

Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Desogestrel; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents; Progestins