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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:
ClinicalTrials.gov Identifier:
NCT00117273
First Posted: July 6, 2005
Last Update Posted: May 9, 2014
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.
Information provided by:
Teva Pharmaceutical Industries
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Teva Pharmaceutical Industries:

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 ]

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 ]
  • Compare differences in ovarian follicular development [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117273     History of Changes
Other Study ID Numbers: DR PSE 310
First Submitted: June 30, 2005
First Posted: July 6, 2005
Last Update Posted: May 9, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic