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

Endometriosis Clinical Trial

Official title:

Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056042
• Other study ID #: EC 50/370-029
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: October 28, 2014
• Start date: June 2007
• Est. completion date: October 2011

Study information

• Verified date: October 2014
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Public Health, Government of Thailand: Thailand
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' satisfaction with the treatment		1 year and 6 months	No
Secondary	pain reduction and adverse side effects		1 year and 6 months	Yes

External Links

•   Faculty of Medicine, Prince of Songkla University