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

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo; Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196365

DR-PSE-305

Details and patient eligibility

About

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 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe menstrual-related pain
• Regular spontaneous menstrual cycles

Exclusion criteria

• Any contraindication to the use of oral contraceptives
• Treatment with an oral contraceptive in the last 3 months
• Previous treatment failure with an extended oral contraceptive regimen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

2

Active Comparator group

Treatment:

Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo