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Completed

NCT Number: NCT00196365

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

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.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

Drug

1 tablet daily

Other names: Seasonique

levonorgestrel/EE 0.15/0.03 mg tablets and placebo

Drug

1 tablet daily

Other names: Portia

Primary outcomes

  1. Change from baseline in the clinical assessment of dysmenorrhea

    Time frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation

Secondary outcomes

  1. Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)

    Time frame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation

  2. Incidence of menstrual bleeding and/or spotting

    Time frame: Duration of study

  3. Analgesic use

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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