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

Phase 2CompletedNCT00196313

Duramed Research95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dysmenorrhea

Interventions

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDRUG

1 tablet daily by mouth

Placebo tabletDRUG

1 tablet daily by mouth

Eligibility

Sex: FEMALEMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (13)

Duramed Investigational Site

Denver, Colorado, United States

Duramed Investigational Site

Decatur, Georgia, United States

Duramed Investigational Site

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Mean Change in Average Severity for Abdominal/Pelvic Pain

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")

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

Secondary Outcomes

Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain

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")

Time frame: Baseline to end of Week 13

Incidence of Menstrual Bleeding and /or Spotting

Time frame: Baseline to end of Week 13

Number of Days Missed From School/Work or Other Activities

Time frame: 13-week treatment period

Analgesic Use

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

Time frame: 13-week treatment period

Data from ClinicalTrials.gov

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