Etonogestrel subdermal implant for the management of endometriosis-associated pain after ovarian-sparing surgery
PHRR211231-004195
NA
NA
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 | Institution and Institution Address | |
|---|---|---|
| Mikaela Erlinda G. Martinez-Bucu | mgmartinez2@upedu.ph | University of the Philippines Manila |
| Name | 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:
- Women aged 18-49 years old
- 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.
- 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
- 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.
- Willing to use an ENG implant for at least 12 months or receive monthly GnRH agonist intramuscular injections for 6 months
Exclusion criteria:
- Women less than 18 years old
- Women more than 49 years old or menopausal
- Desirous of immediate pregnancy (
- 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.
- Psychiatric conditions that may impair answering the questionnaire
- Women who cannot adhere to the follow up schedule (will migrate or return to the province)
- Refusal or inability to sign the informed consent
Interventional
Etonogestrel subdermal implant
None
Randomized
Open Label
Unspecified
Parallel
Unspecified
Not Applicable