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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01056042
Other study ID # EC 50/370-029
Secondary ID
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


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
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