NCT00196313

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

Geographic Reach
1 country

13 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

May 1, 2005

Completed
4 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
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

May 25, 2012

Completed
Last Updated

September 22, 2016

Status Verified

August 1, 2016

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Results QC Date

October 12, 2011

Last Update Submit

August 16, 2016

Conditions

Dysmenorrhea

Keywords

cyclic pelvic paindysmenorrheaoral contraceptives

Outcome Measures

Primary Outcomes (1)

  • 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")

    Baseline to end of 13-week treatment period

Secondary Outcomes (4)

  • Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain

    Baseline to end of Week 13

  • Incidence of Menstrual Bleeding and /or Spotting

    Baseline to end of Week 13

  • Number of Days Missed From School/Work or Other Activities

    13-week treatment period

  • Analgesic Use

    13-week treatment period

Study Arms (2)

1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet

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

2

PLACEBO COMPARATOR
Drug: Placebo tablet

Interventions

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDRUG

1 tablet daily by mouth

Also known as: Seasonique
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
Placebo tabletDRUG

1 tablet daily by mouth

2

Eligibility Criteria

AgeUp to 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Sexually naïve and agree to abstain from sex during the study
  • Moderate to severe menstrual-related pelvic pain
  • Regular spontaneous menstrual cycles

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Duramed Investigational Site

Denver, Colorado, 80218-1088, United States

Location

Duramed Investigational Site

Decatur, Georgia, 30034, United States

Location

Duramed Investigational Site

Louisville, Kentucky, 40202, United States

Location

Duramed Investigational Site

St Louis, Missouri, 63110, United States

Location

Duramed Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Duramed Investigational Site

Cleveland, Ohio, 44109, United States

Location

Duramed Investigational Site

Columbus, Ohio, 43205, United States

Location

Duramed Investigational Site

Medford, Oregon, 97504, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Duramed Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Duramed Investigational Site

Willow Grove, Pennsylvania, 19090, United States

Location

Duramed Investigational Site

Providence, Rhode Island, 02903, United States

Location

Duramed Investigational Site

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Seasonique

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Duramed Research Protocol Chair
Organization
Duramed Research
role_medical_affairs@tevapharm.com
215-293-7279

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 22, 2016

Results First Posted

May 25, 2012

Record last verified: 2016-08

Locations

US(13)