Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea - Full Text View

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00517556

Purpose

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.

Condition	Intervention	Phase
Dysmenorrhea	Drug: Monophasic oral gestodene/ethinyl estradiol	Phase I Phase II

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea

Further study details as provided by Penn State University:

Primary Outcome Measures:

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. [ Time Frame: 6 months ]

Estimated Enrollment:	38
Study Start Date:	August 2007

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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517556

Contacts

Contact: Romana Dmitrovic, M.D.		romana.dmitrovic@zg.htnet.hr
Contact: Richard Legro, M.D.	717-531-8478	rsl1@psu.edu

Locations

Croatia
Nova Gradiska General Hospital	Recruiting
Strossmayerova 17, Croatia
Contact: Romana Dmitrovic, M.D. romana.dmitrovic@zg.htnet.hr
Contact: Sandra Eyer 717-531-1540 seyer@psu.edu

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator:

Richard S Legro, M.D.

Penn State University

More Information

Study ID Numbers:	25239
Study First Received:	May 18, 2007
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00517556
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Dysmenorrhea, continuous OCP

Study placed in the following topic categories:

Signs and Symptoms
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Estradiol 3-benzoate
Estradiol valerate

Ethinyl Estradiol
Pain
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Pathologic Processes
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009