Clinical Trial: Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea

Brief Summary: The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.

Detailed Summary: It is well established that excess prostaglandin production in primary dysmenorrhea (PD) leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid anti-inflammatory drugs (NSAIDs) being the most effective with the overall success rate of more than 75%. Oral contraceptive pills (OCP) are also an established treatment for PD with the success rate of 70%. Lately, OCP's have been used continuously in patients with endometriosis and had better pain control than traditional administration of OCP.
Sponsor: Milton S. Hershey Medical Center

Current Primary Outcome: Change in Visual Analog Scale (VAS) Score [ Time Frame: Baseline and 6 months ]

Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.


Original Primary Outcome: The primary outcome will be the difference in subjective perception of pain as measured by the Visual Analog Scale over the period of six months. [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: May 18, 2007
Date Started: August 2007
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017