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A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens

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: NCT00117273
Recruitment Status : Completed
First Posted : July 6, 2005
Last Update Posted : May 9, 2014
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 6, 2005
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
  • Compare the differences in hormone withdrawal symptoms [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ]
  • Compare differences in ovarian follicular development [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
  • Compare the differences in hormone withdrawal symptoms
  • Compare differences in ovarian follicular development before, during and after the 7-day hormone free interval or ethinyl estradiol-supplemented intervals.
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 Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Official Title  ICMJE A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills
Brief Summary This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
    1 tablet daily
  • Drug: Seasonique (LNG/EE and EE)
    1 tablet daily
  • Drug: Portia (LNG/EE)
    1 tablet daily x 28 days
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Seasonique (LNG/EE and EE)
  • Active Comparator: 2
    Intervention: Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
  • Active Comparator: 3
    Intervention: Drug: Portia (LNG/EE)
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
Estimated Enrollment  ICMJE
 (submitted: June 30, 2005)
36
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premenopausal
  • Not pregnant or breastfeeding
  • Weight <200 lbs
  • Currently taking oral contraceptives in the standard 28-day regimen for at least two months

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy within the last 3 months
  • Smoking > 10 cigarettes per day
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 NCT00117273
Other Study ID Numbers  ICMJE DR PSE 310
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duramed Protocol Chair, Duramed Research, Inc.
Study Sponsor  ICMJE Duramed Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date May 2014

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