Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain

• ClinicalTrials.gov Identifier: NCT01056042
• Recruitment Status: Completed
• First Posted: January 26, 2010
• Last Update Posted: October 29, 2014
• Sponsor: Prince of Songkla University
• Information provided by (Responsible Party): Sopon Cheewadhanaraks, Prince of Songkla University

Tracking Information

• First Submitted Date: January 25, 2010
• First Posted Date: January 26, 2010
• Last Update Posted Date: October 29, 2014
• Study Start Date: June 2007
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 25, 2010): Patients' satisfaction with the treatment [ Time Frame: 1 year and 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01056042 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: January 25, 2010): pain reduction and adverse side effects [ Time Frame: 1 year and 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Endometriosis

Intervention

• Drug: intramuscular depot medroxyprogesterone acetate
  150 mg, Intramuscular, every 3 months
  Other Name: Depo Provera
• Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
  one tablet orally, everyday
  Other Name: Gynera

Study Arms

• Experimental: A
  Intramuscular depot medroxyprogesterone acetate
  Intervention: Drug: intramuscular depot medroxyprogesterone acetate
• Active Comparator: B
  ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
  Intervention: Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 25, 2010): 112
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

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 )

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT01056042
• Other Study ID Numbers: EC 50/370-029
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sopon Cheewadhanaraks, Prince of Songkla University
• Study Sponsor: Prince of Songkla University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sopon Cheewadhanaraks, M.D.; Faculty of Medicine, Prince of Songkla University

• PRS Account: Prince of Songkla University
• Verification Date: October 2014