NCT00517556

Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	CCOCP	(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
DRUG	Traditional OCP	(traditional OCP) (21 active days/7 inactive days) treatment regimen

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2007-08-17
• Last updated: 2017-04-28
• Results posted: 2017-04-28

Locations

1 site across 1 country: Croatia