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Trial record 23 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01291004
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 7, 2011
Last Update Posted Date August 21, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [ Time Frame: 16 weeks ]
  • Change in serum Estradiol level from baseline to week 16. [ Time Frame: 16 weeks ]
  • Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [ Time Frame: 16 weeks ]
  • Change in serum Progesterone level from baseline to week 20. [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01291004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
  • Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ]
  • Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ]
  • 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 ]
  • Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ]
  • Return to ovulation rate at week 20. [ Time Frame: Week 20 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ]
  • Change from baseline to end of week 15 in Plamin-Antiplasmin complex [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ]
  • 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 ]
  • Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ]
  • Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ]
  • Return to ovulation rate at week 20. [ Time Frame: Week 20 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Follicle Development
  • Ovarian Follicle
  • Follicle Count
  • Follicle Size
  • Oral Contraceptive
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2013)
206
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2011)
160
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291004
Other Study ID Numbers  ICMJE DSG-OI-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Study Sponsor  ICMJE Teva Branded Pharmaceutical Products, R&D Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Teva Women's Health Research Protocol Chair Teva Branded Pharmaceutical Products, R&D Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date August 2013

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