A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-10-31

Brief Summary

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This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

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Detailed Description

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Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet

Group Type EXPERIMENTAL

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

Intervention Type DRUG

1 tablet daily by mouth

2

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

1 tablet daily by mouth

Interventions

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levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

1 tablet daily by mouth

Intervention Type DRUG

Placebo tablet

1 tablet daily by mouth

Intervention Type DRUG

Other Intervention Names

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Seasonique

Eligibility Criteria

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Inclusion Criteria

* Sexually naïve and agree to abstain from sex during the study
* Moderate to severe menstrual-related pelvic pain
* Regular spontaneous menstrual cycles

Exclusion Criteria

* Any contraindication to the use of oral contraceptives
* Treatment with an oral contraceptive within the previous 3 months
* Previous treatment failure with an extended oral contraceptive regimen

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No