Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Phase 1

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: CCOCP; Drug: Traditional OCP

• Registration Number: NCT00517556
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2007-05-18
• Study Start: 2007-08
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-17
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Results First Submitted: 2017-01-26
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Results First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group (CCOCP)	CCOCP	treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
control group (traditional OCP)	Traditional OCP	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.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) Score	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.

Trial Locations

Locations (1)

Nova Gradiska General Hospital; 🇭🇷 Strossmayerova 17, Croatia