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

This study has been completed.
Information provided by (Responsible Party):
Sopon Cheewadhanaraks, Prince of Songkla University Identifier:
First received: January 25, 2010
Last updated: October 28, 2014
Last verified: October 2014
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
Drug: intramuscular depot medroxyprogesterone acetate
Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • pain reduction and adverse side effects [ Time Frame: 1 year and 6 months ]

Estimated Enrollment: 112
Study Start Date: June 2007
Study Completion Date: October 2011
Primary Completion Date: April 2011 (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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 )
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Please refer to this study by its identifier: NCT01056042

Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Principal Investigator: Sopon Cheewadhanaraks, M.D. Faculty of Medicine, Prince of Songkla University
  More Information

Additional Information:
Responsible Party: Sopon Cheewadhanaraks, Associate Professor, Prince of Songkla University Identifier: NCT01056042     History of Changes
Other Study ID Numbers: EC 50/370-029
Study First Received: January 25, 2010
Last Updated: October 28, 2014

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

Additional relevant MeSH terms:
Genital Diseases, Female
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Medroxyprogesterone Acetate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins processed this record on May 22, 2017