NCT00196365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

September 12, 2005

Last Update Submit

May 9, 2014

Conditions

Dysmenorrhea

Keywords

cyclic pelvic paindysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the clinical assessment of dysmenorrhea

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

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

2

ACTIVE COMPARATOR
Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo

Interventions

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDRUG

1 tablet daily

Also known as: Seasonique
1
levonorgestrel/EE 0.15/0.03 mg tablets and placeboDRUG

1 tablet daily

Also known as: Portia
2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Moderate to severe menstrual-related pain
  • Regular spontaneous menstrual cycles

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Duramed Investigational Site

Huntsville, Alabama, 35801, United States

Location

Duramed Investigational Site

Phoenix, Arizona, 85032, United States

Location

Duramed Investigational Site

San Diego, California, 92108, United States

Location

Duramed Investigational Site

Denver, Colorado, 80202, United States

Location

Duramed Investigational Site

Tampa, Florida, 33607, United States

Location

Duramed Investigational Site

Decatur, Georgia, 30034, United States

Location

Duramed Investigational Site

Moorestown, New Jersey, 08057, United States

Location

Duramed Investigational Site

Charlotte, North Carolina, 28222, United States

Location

Duramed Investigational Site

Columbus, Ohio, 43205, United States

Location

Duramed Investigational Site

Columbus, Ohio, 43213, United States

Location

Duramed Investigational Site

Medford, Oregon, 97504, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Duramed Investigational Site

Memphis, Tennessee, 38120, United States

Location

Duramed Investigational Site

Salt Lake City, Utah, 84124, United States

Location

Duramed Investigational Site

Newport News, Virginia, 23602, United States

Location

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

Location

Duramed Investigational Site

Spokane, Washington, 99207, United States

Location

Duramed Investigational Site

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

SeasoniqueEthinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Ethinyl EstradiolNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Duramed Protocol Chair

    Duramed Research, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(18)