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Etonogestrel subdermal implant for the management of endometriosis-associated pain after ovarian-sparing surgery

PHRR211231-004195

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Etonogestrel subdermal implant for the management of endometriosis-associated pain after ovarian-sparing surgery

This study aims to determine efficacy of ENG subdermal implant as management for endometriosis-associated pain after ovarian-sparing surgery compared to the GnRH agonist. At optimal dosing, GnRH agonist has been proven to be the most effective in reducing endometriosis-associated pain. However, the side effects brought about by its pseudomenopausal state is frequent and bothersome. This compromises patient compliance especially for long-term treatment of endometriosis.

ENG implant is potentially an effective alternative treatment for endometriosis-associated pain due to its prolonged progestogen effect. Its tolerability and efficacy as a contraceptive have already been well established. The ENG implant has the potential to be a safe, effective and convenient alternative treatment for postoperative endometriosis-related pain. It can be a valid option for patients not eligible for LNG-IUS insertion or for those who cannot tolerate the bothersome side effects of GnRH agonist.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Reproductive health
Start Date Duration in Months Target Completion Date Actual Completion Date
2022-02-01 36 2025-02-01 2024-02-01

Pending

Awaiting funds

Institution Classification Region LTO #
UP Manila Government NCR NA
Institution Region
Merck Sharp & Dohme Corporation United States of America
Name E-Mail Institution and Institution Address
Mikaela Erlinda G. Martinez-Bucu mgmartinez2@upedu.ph University of the Philippines Manila
Name E-Mail Institution and Institution Address
Mikaela Erlinda G. Martinez-Buu mgmartinez2@up.edu.ph University of the Philippines Manila
Name Expertise Affiliation
Maria Antonia Esteban Habana Obstetrics and Gynecology UP Manila
Mikaela Erlinda Germar Martinez-Bucu Obstetrics and Gynecology UP Manila
Project Location Institutional Ethics Review Board
UP Manila University of the Philippines Manila - Research Ethics Board
UP Manila University of the Philippines Manila - Research Ethics Board

Postoperative medical management of pelvic endometriosis

Outcome : Pain control

Method of measurement: VAS Scores for endometriosis-related pain (worst pain)

Timepoint: Baseline then 1 month, 3 months, 6 months, 12 months after surgery

 

Outcome: Health-related Quality of Life

Method of measurement: EHP-30 Long Form Questionnaire

Timepoint: Baseline then 3 months, 6 months, 12 months after surgery

 

Outcome: Treatment satisfaction

Method of measurement: SATMED-Q

Timepoint: 3 months, 6 months, 12 months after surgery

 

 

Outcome: Effects on bone mineral density

Method of measurement: Dexa Bone Scan

Timepoint: Baseline then 6 months after surgery

 

Outcome: Response to medical treatment

Method of measurement: CA-125

Timepoint: Baseline then 3 months and 6 months after surgery

Pending

Clinical Trial

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The study population will include premenopausal women aged 18-49 years old who are diagnosed with endometriosis and are scheduled to undergo ovarian-sparing surgery.

 

Inclusion criteria:

  1. Women aged 18-49 years old
  2. With symptomatic painful dysmenorrhea or noncyclic chronic pelvic pain for more than 6 months. Pelvic pain is defined as pain at the lower portion of the abdomen or pelvis. This may or may not be associated with menses. Dysmenorrhea is pelvic pain associated with the menses. A pretreatment visual analog scale (VAS) score of more than or equal to 3 will be included in the study.
  3. Women who are scheduled to undergo ovarian-sparing surgery for endometriosis by exploratory laparotomy or laparoscopy. This includes the following procedures: excision of ovarian cyst, fulguration of implants, diagnostic laparoscopy, total hysterectomy with or without salpingectomy
  4. No previous hormonal treatment for at least 4 weeks from enrollment in the study. For patients previously given depot GnRH agonist 11.25 mg and depot medroxyprogesterone acetate, a wash out period of at least 3 months will be required to ensure that residual effects of these medical interventions do not contribute to the alleviation of pain as the primary outcome measure.
  5. Willing to use an ENG implant for at least 12 months or receive monthly GnRH agonist intramuscular injections for 6 months

 Exclusion criteria:

  1. Women less than 18 years old
  2. Women more than 49 years old or menopausal
  3. Desirous of immediate pregnancy (
  4. Suspicion of malignancy

Malignancy is suspected if the patient had rapid abdominal growth, weight loss, anorexia and low-grade fever. Sonologic findings that may point to a malignancy include a solid mass, multiloculated mass with excrescences, thickened septations, ascites and increased color flow with low resistance indices on doppler studies.

  1. Psychiatric conditions that may impair answering the questionnaire
  2. Women who cannot adhere to the follow up schedule (will migrate or return to the province)
  3. Refusal or inability to sign the informed consent

Interventional

Etonogestrel subdermal implant

None

Randomized

Open Label

Unspecified

Parallel

Unspecified

Not Applicable

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
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