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Completed

NCT Number: NCT00196313

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 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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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

Drug

1 tablet daily by mouth

Other names: Seasonique

Placebo Tablet

Drug

1 tablet daily by mouth

Primary outcomes

  1. Mean Change in Average Severity for Abdominal/Pelvic Pain

    Time frame: Baseline to end of 13-week treatment period

    Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")

Secondary outcomes

  1. Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain

    Time frame: Baseline to end of Week 13

    Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.

    The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")

  2. Incidence of Menstrual Bleeding and /or Spotting

    Time frame: Baseline to end of Week 13

  3. Number of Days Missed From School/Work or Other Activities

    Time frame: 13-week treatment period

  4. Analgesic Use

    Time frame: 13-week treatment period

    number of days analgesic (pain) medication was used over the 13 week treatment period

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Sep 22, 2016

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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