NCT00212342

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

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

December 1, 2004

Completed
10 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

September 6, 2010

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS

Secondary Outcomes (5)

  • changes in the VAS of dysmenorrhea.

  • changes in the VRS of non-menstrual pain.

  • changes in the VAS of non-menstrual pain.

  • changes in the clinical evaluation of pelvic induration.

  • changes in the size of ovarian endometrioma.

Study Arms (2)

Norethisterone,Ethinylestradiol

EXPERIMENTAL
Drug: Norethisterone,Ethinylestradiol

Sugar pill

PLACEBO COMPARATOR
Drug: Sugar pill

Interventions

Norethisterone,EthinylestradiolDRUG
Norethisterone,Ethinylestradiol
Sugar pillDRUG
Sugar pill

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

NorethindroneEthinyl EstradiolSugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCarbohydrates

Study Officials

  • Naoki Terakawa, M.D.,Ph.D.

    Tottori University,Tottori,Japan

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2004

Primary Completion

January 1, 2006

Study Completion

March 1, 2006

Last Updated

September 8, 2010

Record last verified: 2010-09