Clinical trial NCT00517556: Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Official title: Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
continuous OCP
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy women ages 18-35 with a history of PD (onset \< 3 years after menarche).
* Subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe PD during those cycles.

Exclusion Criteria:

* Patients who have contraindications to OCP therapy.
* Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).
* Concomitant treatment with oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
* The use of contraceptive implants, injectable contraceptives or intrauterine devices. The washout period on all these medications will be 3 months.
* Migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use.
* Known or suspected hypersensitivity to trial drug.
* Patients enrolled simultaneously into other investigative studies that require meds.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strossmayerova 17
country: Croatia
facility: Nova Gradiska General Hospital
Study officials:
affiliation: Penn State University
name: Richard S Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dmitrovic R, Kunselman AR, Legro RS. Continuous compared with cyclic oral contraceptives for the treatment of primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1143-50. doi: 10.1097/AOG.0b013e318257217a.