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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Intramuscular depot medroxyprogesterone acetate

Group Type EXPERIMENTAL

intramuscular depot medroxyprogesterone acetate

Intervention Type DRUG

150 mg, Intramuscular, every 3 months

B

ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms

Group Type ACTIVE_COMPARATOR

ethinyl estradiol 30 micrograms, gestodene 75 micrograms

Intervention Type DRUG

one tablet orally, everyday

Interventions

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intramuscular depot medroxyprogesterone acetate

150 mg, Intramuscular, every 3 months

Intervention Type DRUG

ethinyl estradiol 30 micrograms, gestodene 75 micrograms

one tablet orally, everyday

Intervention Type DRUG

Other Intervention Names

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Depo Provera Gynera

Eligibility Criteria

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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 )

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No