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

Prince of Songkla University

Status and phase: Completed; Phase 4

Conditions: Endometriosis

Treatments: Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms; Drug: intramuscular depot medroxyprogesterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01056042

EC 50/370-029

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

A

Experimental group

Description:

Intramuscular depot medroxyprogesterone acetate

Treatment:

Drug: intramuscular depot medroxyprogesterone acetate

B

Active Comparator group

Description:

ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms

Treatment:

Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms