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OpenTrials
Completed

NCT Number: NCT01056042

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

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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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

intramuscular depot medroxyprogesterone acetate

Drug

150 mg, Intramuscular, every 3 months

Other names: Depo Provera

ethinyl estradiol 30 micrograms, gestodene 75 micrograms

Drug

one tablet orally, everyday

Other names: Gynera

Primary outcomes

  1. Patients' satisfaction with the treatment

    Time frame: 1 year and 6 months

Secondary outcomes

  1. pain reduction and adverse side effects

    Time frame: 1 year and 6 months

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2010
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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