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Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (Dysmenorrhea)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517556
First Posted: August 17, 2007
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
  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: CCOCP Drug: Traditional OCP Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change in Visual Analog Scale (VAS) Score [ Time Frame: 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.


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)
Arms Assigned Interventions
Experimental: study group (CCOCP)
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
Drug: CCOCP
(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
Other Name: Oral contraceptives
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.
Drug: Traditional OCP
(traditional OCP) (21 active days/7 inactive days) treatment regimen
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

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 18, 2007
First Posted: August 17, 2007
Results First Submitted: January 26, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: March 2017

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Dysmenorrhea
continuous OCP

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Estradiol
Ethinyl Estradiol
Gestodene
Contraceptive Agents
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Progestins