Back to resultsEfficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
intramuscular depot medroxyprogesterone acetate
ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring pelvic pain, postoperative, medical therapy
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.
Exclusion Criteria:
- Medical therapies for endometriosis other than NSAID within previous 6 months
- Contraindication to the drugs
- Wish to conceive
- Request for extirpative surgery
- Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
Sites / Locations
- Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Intramuscular depot medroxyprogesterone acetate
ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
Outcomes
Primary Outcome Measures
Patients' satisfaction with the treatment
Secondary Outcome Measures
pain reduction and adverse side effects
Full Information
NCT ID
NCT01056042
First Posted
January 25, 2010
Last Updated
October 28, 2014
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01056042
Brief Title
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Official Title
Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
pelvic pain, postoperative, medical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Intramuscular depot medroxyprogesterone acetate
Arm Title
B
Arm Type
Active Comparator
Arm Description
ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
Intervention Type
Drug
Intervention Name(s)
intramuscular depot medroxyprogesterone acetate
Other Intervention Name(s)
Depo Provera
Intervention Description
150 mg, Intramuscular, every 3 months
Intervention Type
Drug
Intervention Name(s)
ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Other Intervention Name(s)
Gynera
Intervention Description
one tablet orally, everyday
Primary Outcome Measure Information:
Title
Patients' satisfaction with the treatment
Time Frame
1 year and 6 months
Secondary Outcome Measure Information:
Title
pain reduction and adverse side effects
Time Frame
1 year and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.
Exclusion Criteria:
Medical therapies for endometriosis other than NSAID within previous 6 months
Contraindication to the drugs
Wish to conceive
Request for extirpative surgery
Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sopon Cheewadhanaraks, M.D.
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
12969698
Citation
Vercellini P, Frontino G, De Giorgi O, Pietropaolo G, Pasin R, Crosignani PG. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003 Sep;80(3):560-3. doi: 10.1016/s0015-0282(03)00794-5.
Results Reference
background
Links:
URL
http://medinfo.psu.ac.th
Description
Faculty of Medicine, Prince of Songkla University
Learn more about this trial
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
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