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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196365

Enrollment

Registered

2005-09-20

Start date

2005-01-31

Completion date

2007-07-31

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

Keywords

cyclic pelvic pain, dysmenorrhea

Brief summary

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.

Interventions

DRUGlevonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

1 tablet daily

DRUGlevonorgestrel/EE 0.15/0.03 mg tablets and placebo

1 tablet daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the clinical assessment of dysmenorrhea	Baseline to Week 4,8,12,24, and 26 or early discontinuation

Secondary

Measure	Time frame
Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)	Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
Incidence of menstrual bleeding and/or spotting	Duration of study
Analgesic use	Duration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026