Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (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: January 16, 2015
Last verified: January 2015

May 18, 2007
January 16, 2015
August 2007
March 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00517556 on ClinicalTrials.gov Archive Site
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Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dysmenorrhea
  • Drug: Continuous Monophasic oral gestodene/ethinyl estradiol treatment
    (CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
    Other Name: Oral contraceptives
  • Drug: Traditional Monophasic oral gestodene/ethinyl estradiol treatment
    (traditional OCP) (21 active days/7 inactive days) treatment regimen
    Other Name: Oral contraceptives
  • Experimental: study group (CCOCP)
    treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
    Intervention: Drug: Continuous Monophasic oral gestodene/ethinyl estradiol treatment
  • Active Comparator: control group (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.
    Intervention: Drug: Traditional Monophasic oral gestodene/ethinyl estradiol treatment
Dmitrovic R, Kunselman AR, Legro RS. Continuous compared with cyclic oral contraceptives for the treatment of primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1143-50. doi: 10.1097/AOG.0b013e318257217a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
April 2011
March 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00517556
25239
No
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Richard S. Legro, M.D., Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Richard S Legro, M.D. Penn State University
Milton S. Hershey Medical Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP