Skip to main content
OpenTrials
Completed

NCT Number: NCT00212342

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • dysmenorrhea associated with endometriosis

Exclusion criteria

  • severe hepatopathy
  • pregnant woman

Treatment and study plan

Norethisterone,Ethinylestradiol

Drug

Sugar pill

Drug

Primary outcomes

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

Secondary outcomes

  1. changes in the VAS of dysmenorrhea.

  2. changes in the VRS of non-menstrual pain.

  3. changes in the VAS of non-menstrual pain.

  4. changes in the clinical evaluation of pelvic induration.

  5. changes in the size of ovarian endometrioma.

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Official study title

Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Sep 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.