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Trial record 19 of 25 for:    gestodene

Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (Dysmenorrhea)

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. Identifier: NCT00517556
Recruitment Status : Completed
First Posted : August 17, 2007
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: CCOCP Drug: Traditional OCP Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: study group (CCOCP)
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
(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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00517556

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center Identifier: NCT00517556     History of Changes
Other Study ID Numbers: 25239
First Posted: August 17, 2007    Key Record Dates
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:
continuous OCP
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic