Endometriosis Clinical Trial
Official title:
Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | October 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 ) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Prince of Songkla University | Hat Yai | Songkla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients' satisfaction with the treatment | 1 year and 6 months | No | |
Secondary | pain reduction and adverse side effects | 1 year and 6 months | Yes |
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