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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Prince of Songkla University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sopon Cheewadhanaraks, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01056042
First received: January 25, 2010
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: intramuscular depot medroxyprogesterone acetate
Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Patients' satisfaction with the treatment [ Time Frame: 1 year and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain reduction and adverse side effects [ Time Frame: 1 year and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: June 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Intramuscular depot medroxyprogesterone acetate
Drug: intramuscular depot medroxyprogesterone acetate
150 mg, Intramuscular, every 3 months
Other Name: Depo Provera
Active Comparator: B
ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
one tablet orally, everyday
Other Name: Gynera

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056042

Contacts
Contact: Sopon Cheewadhanaraks, M.D. 66 74 451158 csophon@medicine.psu.ac.th
Contact: Krantarat Peeyananjarassri, M.D. 66 74 281201 Krantatat@yahoo.com

Locations
Thailand
Faculty of Medicine, Prince of Songkla University Recruiting
Hat Yai, Songkla, Thailand, 90110
Contact: Sumet Peeravud, M.D.    66 74 451100    psumet@medicine.psu.ac.th   
Contact: Verapol Chandeying, M.D.    66 74 451149    verapol.c@psu.ac.th   
Principal Investigator: Sopon Cheewadhanaraks, M.D.         
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Sopon Cheewadhanaraks, M.D. Faculty of Medicine, Prince of Songkla University
  More Information

Additional Information:
Publications:
Responsible Party: Sopon Cheewadhanaraks, Associate Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01056042     History of Changes
Other Study ID Numbers: EC 50/370-029
Study First Received: January 25, 2010
Last Updated: September 22, 2011
Health Authority: Ministry of Public Health, Government of Thailand: Thailand

Keywords provided by Prince of Songkla University:
pelvic pain
postoperative
medical therapy

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Contraceptive Agents
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Medroxyprogesterone
Medroxyprogesterone Acetate
Gestodene
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins

ClinicalTrials.gov processed this record on August 19, 2014