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

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]; Drug: Portia (LNG/EE); Drug: Seasonique (LNG/EE and EE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117273

DR PSE 310

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Seasonique (LNG/EE and EE)

2

Active Comparator group

Treatment:

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

3

Active Comparator group

Treatment:

Drug: Portia (LNG/EE)