NCT00212277

Brief Summary

The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2005

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

September 9, 2010

Conditions

Dysmenorrhea

Interventions

Norethindrone,Ethinyl EstradiolDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dysmenorrhea associated with endometriosis

You may not qualify if:

  • severe hepatopathy
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

ovcon 35

Condition Hierarchy (Ancestors)

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

Study Officials

  • Naoki Terakawa, M.D.,Ph.D.

    Tottori University,Tottori,Japan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2005

Primary Completion

September 1, 2006

Study Completion

February 1, 2007

Last Updated

September 10, 2010

Record last verified: 2010-09