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Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (Dysmenorrhea)

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 1
Locations
Croatia
Study Type
Interventional
Intervention
CCOCP
Traditional OCP
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, continuous OCP

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Nova Gradiska General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group (CCOCP)

control group (traditional OCP)

Arm Description

treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles

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.

Outcomes

Primary Outcome Measures

Change in Visual Analog Scale (VAS) Score
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.

Secondary Outcome Measures

Full Information

First Posted
May 18, 2007
Last Updated
March 20, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00517556
Brief Title
Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Acronym
Dysmenorrhea
Official Title
Continuous Administration of a Monophasic Oral Contraceptive in the Treatment of Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Dysmenorrhea, continuous OCP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group (CCOCP)
Arm Type
Experimental
Arm Description
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
Arm Title
control group (traditional OCP)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
CCOCP
Other Intervention Name(s)
Oral contraceptives
Intervention Description
(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
Intervention Type
Drug
Intervention Name(s)
Traditional OCP
Other Intervention Name(s)
Oral contraceptives
Intervention Description
(traditional OCP) (21 active days/7 inactive days) treatment regimen
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Score
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Legro, M.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Gradiska General Hospital
City
Strossmayerova 17
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22617578
Citation
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.
Results Reference
derived

Learn more about this trial

Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

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