Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Dysmenorrhea Clinical Trial

— Dysmenorrhea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517556
• Other study ID #: 25239
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 18, 2007
• Last updated: January 16, 2015
• Start date: August 2007
• Est. completion date: April 2011

Study information

• Verified date: January 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Continuous Monophasic oral gestodene/ethinyl estradiol treatment
(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
• Traditional Monophasic oral gestodene/ethinyl estradiol treatment
(traditional OCP) (21 active days/7 inactive days) treatment regimen

Locations

Country	Name	City	State
Croatia	Nova Gradiska General Hospital	Strossmayerova 17

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No