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

Phase 4

Completed

• Conditions: Endometriosis
• Interventions: Drug: intramuscular depot medroxyprogesterone acetate; Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms

• Registration Number: NCT01056042
• Lead Sponsor: Prince of Songkla University

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 available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2011-04
• Study Completion: 2011-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	intramuscular depot medroxyprogesterone acetate	Intramuscular depot medroxyprogesterone acetate
B	ethinyl estradiol 30 micrograms, gestodene 75 micrograms	ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms

Primary Outcome Measures

Name	Time	Method
Patients' satisfaction with the treatment	1 year and 6 months

Secondary Outcome Measures

Name	Time	Method
pain reduction and adverse side effects	1 year and 6 months

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand