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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00117273
First received: June 30, 2005
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Healthy
 Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
Drug: Seasonique (LNG/EE and EE)
Drug: Portia (LNG/EE)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the differences in hormone withdrawal symptoms [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ] [ Designated as safety issue: No ]
  • Compare differences in ovarian follicular development [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2005
Estimated Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1 Drug: Seasonique (LNG/EE and EE)
1 tablet daily
Active Comparator: 2 Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
1 tablet daily
Active Comparator: 3 Drug: Portia (LNG/EE)
1 tablet daily x 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117273

Locations
United States, Texas
Duramed Investigational Site
Temple, Texas, United States, 76508
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

Additional Information:
Mayo Clinic - Birth Control Guide  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117273     History of Changes
Other Study ID Numbers: DR PSE 310
Study First Received: June 30, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
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

ClinicalTrials.gov processed this record on May 16, 2013