Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: CCOCP
* Drug: Traditional OCP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group (CCOCP)<br>treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles | Drug: CCOCP<br>* (CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol<br>* Other names: Oral contraceptives;|
| Active Comparator: control group (traditional OCP)<br>treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles. | Drug: Traditional OCP<br>* (traditional OCP) (21 active days/7 inactive days) treatment regimen<br>* Other names: Oral contraceptives;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Score | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysmenorrhea, continuous OCP