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

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Estradiol Ethinyl Estradiol Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Estradiol hemihydrate Desogestrel Drospirenone

U.S. FDA Resources

Further study details as provided by Teva Women's Health:

Primary Outcome Measures:

Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in serum Estradiol level from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in serum Progesterone level from baseline to week 20. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Return to ovulation rate at week 20. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2011
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291004

Locations

United States, Pennsylvania
Teva Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Washington
Teva Investigational Site
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Teva Women's Health

Investigators

Study Chair:

Teva Women's Health Research Protocol Chair

Teva Branded Pharmaceutical Products, R&D Inc.

More Information

No publications provided

Responsible Party:	Teva Women's Health
ClinicalTrials.gov Identifier:	NCT01291004 History of Changes
Other Study ID Numbers:	DSG-OI-101
Study First Received:	February 4, 2011
Last Updated:	February 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Desogestrel
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Aldosterone Antagonists
Hormone Antagonists
Progestins

ClinicalTrials.gov processed this record on May 16, 2013