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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196313

DR-PSE-306

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 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.

Enrollment: 95 patients

Sex: Female

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups, including a placebo group

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

Experimental group

Treatment:

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

2

Placebo Comparator group

Treatment:

Drug: Placebo tablet