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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Seasonique (LNG/EE and EE)

Intervention Type DRUG

1 tablet daily

2

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

1 tablet daily

3

Group Type ACTIVE_COMPARATOR

Portia (LNG/EE)

Intervention Type DRUG

1 tablet daily x 28 days

Interventions

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

1 tablet daily

Intervention Type DRUG

Seasonique (LNG/EE and EE)

1 tablet daily

Intervention Type DRUG

Portia (LNG/EE)

1 tablet daily x 28 days

Intervention Type DRUG

Eligibility Criteria

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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