Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 29, 2014
October 1, 2014
3.8 years
January 25, 2010
October 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients' satisfaction with the treatment
1 year and 6 months
Secondary Outcomes (1)
pain reduction and adverse side effects
1 year and 6 months
Study Arms (2)
A
EXPERIMENTALIntramuscular depot medroxyprogesterone acetate
B
ACTIVE COMPARATORethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
Interventions
150 mg, Intramuscular, every 3 months
one tablet orally, everyday
Eligibility Criteria
You may qualify if:
- Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
Related Publications (1)
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.
PMID: 12969698BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sopon Cheewadhanaraks, M.D.
Faculty of Medicine, Prince of Songkla University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
June 1, 2007
Primary Completion
April 1, 2011
Study Completion
October 1, 2011
Last Updated
October 29, 2014
Record last verified: 2014-10