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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01291004
First received: February 4, 2011
Last updated: August 20, 2013
Last verified: August 2013

February 4, 2011
August 20, 2013
January 2011
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01291004 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 Plamin-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 ]
Not Provided
Not Provided
 
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Follicle Development
  • Ovarian Follicle
  • Follicle Count
  • Follicle Size
  • Oral Contraceptive
  • Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
    Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
  • Drug: 28-day drospirenone oral contraceptive
    Drospirenone/ethinyl estradiol 0.3/0.02 mg
  • Drug: 28-day levonorgestrel oral contraceptive
    Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
  • Experimental: 28-day Desogestrel Oral Contraceptive
    Intervention: Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
  • Active Comparator: 28-day Drospirenone Oral Contraceptive
    Intervention: Drug: 28-day drospirenone oral contraceptive
  • Active Comparator: 28-day Levonorgestrel Oral Contraceptive
    Intervention: Drug: 28-day levonorgestrel oral contraceptive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291004
DSG-OI-101
No
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Study Chair: Teva Women's Health Research Protocol Chair Teva Branded Pharmaceutical Products, R&D Inc.
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP