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

Oral Contraceptive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291004
• Other study ID #: DSG-OI-101
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2011
• Est. completion date: March 31, 2012

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 31, 2012
• Est. primary completion date: March 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Follicle Count
• Follicle Development
• Follicle Size
• Oral Contraceptive
• Ovarian Follicle

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Teva Investigational Site 10119	Philadelphia	Pennsylvania
United States	Teva Investigational Site 10118	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.		16 weeks
Primary	Change in serum Estradiol level from baseline to week 16.		16 weeks
Primary	Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.		16 weeks
Primary	Change in serum Progesterone level from baseline to week 20.		20 weeks
Secondary	Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.		15 weeks
Secondary	Change from baseline to week 15 in D-dimer.		15 weeks
Secondary	Change from baseline to end of week 15 in Plasmin-Antiplasmin complex		15 weeks
Secondary	Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).		15 weeks
Secondary	Change from baseline to week 15 in Fibrinogen.		15 weeks
Secondary	Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.		15 weeks
Secondary	Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).		15 weeks
Secondary	Change from baseline to week 15 in Antithrombin.		15 weeks
Secondary	Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).		15 weeks
Secondary	Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).		15 weeks
Secondary	Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).		15 weeks
Secondary	Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).		15 weeks
Secondary	Return to ovulation rate at week 20.		Week 20