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

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

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : June 2007
Primary Completion Date : April 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Patients' satisfaction with the treatment [ Time Frame: 1 year and 6 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056042


Locations
Thailand
Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
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
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Gestodene
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral
Estrogens
Hormones
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