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Completed

NCT Number: NCT00117273

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

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).

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site

Temple, Texas, 76508, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]

Drug

1 tablet daily

Seasonique (LNG/EE and EE)

Drug

1 tablet daily

Portia (LNG/EE)

Drug

1 tablet daily x 28 days

Primary outcomes

  1. 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 outcomes

  1. Compare the differences in hormone withdrawal symptoms

    Time frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval

  2. Compare differences in ovarian follicular development

    Time frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Jul 6, 2005
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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