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Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00517556
First received: May 18, 2007
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

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 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Monophasic oral gestodene/ethinyl estradiol
    Monophasic oral gestodene/ethinyl estradiol
    Other Name: Oral contraceptives
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

Locations
Croatia
Nova Gradiska General Hospital
Strossmayerova 17, Croatia
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Richard S Legro, M.D. Penn State University
  More Information

No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00517556     History of Changes
Other Study ID Numbers: 25239
Study First Received: May 18, 2007
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Dysmenorrhea
continuous OCP

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Gestodene
Contraceptives, Oral
Estradiol
 Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Progestins

ClinicalTrials.gov processed this record on May 22, 2013