Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment
Endometriosis · Pelvic Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - 50 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 100 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet. PK profile of the gestrinone pellet will be monitored.
Read the full description
This is a Phase 2, exploratory, multicenter, randomized, double-blind, placebo-controlled study followed by an optional open-label pharmacokinetic extension.
This study aimed to assess the safety and tolerability profile of a subdermal 85-mg gestrinone bioabsorbable implant compared with a matched placebo bioabsorbable implant, in women with endometriosis-associated pelvic pain. The pharmacokinetics of the gestrinone implant will be monitored. Exploratory efficacy analyses will be descriptively reported for participant satisfaction, change in pelvic pain intensity, use of rescue pain medication, and quality of life.
One hundred patients will be randomized in a 1: 1 ratio. Initially, all the patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena) as a contraceptive method. On the same day, after randomization, the subdermal implantation of the gestrinone (85 mg) or placebo pellet will be performed. Visits will occur after 3 and 6 months of the pellet insertion. Primary endpoint is a combination of serious adverse events (SAEs) accumulated within 6 months of pellet insertion and collected through spontaneous reporting and/or clinical findings.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria
1. Willingness to provide informed consent
2. Woman aged between 18 and 50 years
3. Body weight between 50 ± 5 kg and 90 ± 5 kg
4. Having pelvic pain secondary to endometriosis, independent of pain intensity
5. Endometriosis documented by biopsies (histopathological examination)
6. Last endometriosis surgery at least 3 months before randomization
7. Not planning to become pregnant within 12 months after the screening visit or be surgically sterilized
8. Absence of changes in the breast (BI-RADS1 and BIRADS-2 classification) documented by an imaging report (mammogram for women aged \> 40 years or bilateral breast ultrasound for women aged \< 40 years) performed less than 12 months before randomization
9. Agreement not to use other hormones (estrogens, androgens and progestins) in any pharmaceutical form during the study
Exclusion Criteria
1. Chronic severe disorders, including metastatic malignancies, end-stage renal disease with or without dialysis, clinically unstable heart disease, or any other disorder that, in the opinion of the investigator, excludes the participant from the study
2. Suspected or confirmed diagnosis of immunodeficiency based on medical history and/or physical or laboratory examination
3. Other medical or psychiatric conditions, including recent laboratory abnormalities (within the last 12 months) that may increase risks to the study participant or, at the discretion of the investigator, make the participant inappropriate for the study
4. Personal history of thromboembolic events
5. Use anticoagulant medication
6. Contraindication to the use of hormonal contraceptives
7. Suspected or confirmed pregnancy
8. Breastfeeding
9. Current or recurrent pelvic inflammatory disease or other conditions that increase the risk of pelvic infections
10. Postpartum endometritis or septic miscarriage in the last 3 months
11. Abnormal uterine bleeding of unknown etiology
12. Congenital or acquired uterine anomalies, including fibroids (leiomyomas or fibromas) that cause distortion of the uterine cavity
13. Uterine or cervical malignancy
14. Suspected or confirmed diagnosis of estrogen-dependent neoplasm, including breast cancer
15. Cervicitis or vaginitis, including bacterial vaginosis or another uncontrolled lower urinary tract infection
16. Cervical dysplasia
17. Active liver disease or dysfunction
18. Benign or malignant liver tumors
19. Allergy or intolerance to levonorgestrel, gestrinone or any other ingredient or component of the Kyleena® formulation or hormonal pellets
20. Previously inserted intrauterine device or levonorgestrel-releasing intrauterine system that has not been removed
21. History of recent trophoblastic disease and continued high HCG levels
22. Bacterial endocarditis
23. Hyperandrogenism at the time of randomization, defined by: hirsutism: Ferriman-Gallwey score ≥ 8; clitoromegaly: defined by the Clitoral index ≥ 35 mm2, acne: defined by the IGA scale (Investigator's global assessment) grade 5 - severe inflammatory acne dominates the area and there is a large number of comedones, pustules, papules and cystic acne; alopecia with sequelae of scalp thinning
24. Diagnosis of polycystic ovary syndrome
25. Participation in another pharmacotherapeutic or investigational medical device study within 30 days prior to the start of study treatment
26. Tobacco Use
27. Use of testosterone-derived hormones and analogues in the last month
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Gestrinone
Subdermal implant-bioabsorbable gestrinone pellet (85 mg) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method
Drug: Gestrinone
Placebo
Subdermal implant-bioabsorbable placebo pellet (cholesterol) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method
Drug: Placebo
Gestrinone DRUG
The intradermal gestrinone/placebo pellet will be inserted on the same day as the levonorgestrel intrauterine hormonal device (Kyleena®)
Placebo DRUG
Subdermal implant-bioabsorbable placebo pellet (cholesterol)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Combination of serious adverse events (SAEs) accumulated within 6 months of gestrinone or placebo pellet insertion and collected through spontaneous reporting and/or clinical findings
Time frame: From randomization to the end of study on 6 months after insertion of the gestrinone or placebo pellet
The primary safety outcome will be the proportion of patients who present serious adverse events (SAEs) over 6 months after randomization, defined as a combination of death, conditions that threat or present risk to life, conditions needing hospitalization or prolonging the pre-existing hospitalization, conditions causing disability or permanent damage, conditions leading to a congenital anomaly and any other significant medical occurrence that, based on appropriate medical judgment, may harm the participant and/or require medical or surgical intervention to prevent any of the other aforementioned occurrences.
In this study, the occurrence of thromboembolic events (such as, for example, acute myocardial infarction, pulmonary embolism, deep vein thrombosis, ischemic stroke, and transient ischemic attack) was predefined as a significant medical event.
Secondary measures
Androgenization
Time frame: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
Number of participants who experience androgenization defined by: Hirsutism (Ferriman-Gallwey Score ≥ 8), Clitoromegaly (Clitoridian index ≥ 35 mm2), Acne (IGA scale grade 5 - severe inflammatory acne dominates the area and there are large numbers of comedones, pustules, papules, and cystic acne), Alopecia, oiliness of the skin, and deepening of the voice
Plasma concentration of steroid hormones
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with clinically relevant laboratory values outside the reference range for plasma concentration of total testosterone, free testosterone, and SHBG
Lipid profile
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with clinically relevant laboratory values outside the reference range for serum levels of total cholesterol, HDL-C, VLDL-C, and triglycerides
Hematological disorders
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with decreased lymphocyte count \< 500/mm3 (or \< 0.5 × 109/l); decrease in neutrophil count \< 500/mm3 (or \< 0.5 × 109/l); decrease in platelet count \< 30,000/mm3 (or \< 30.0 × 109/l); and anemia with decreased Hb \< 7.0 g/dl (or \< 4.35 mmol/l)
Hepatic adverse events
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with increased ALT or AST \> 3 times ULN or baseline, alterations in ALT levels suspected hepatocellular or cholestatic hepatotoxicity
Renal adverse events
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with increased serum creatinine ≥ 1.5 times ULN or baseline; clinically significant increase in serum urea
Other measures
Overall participant satisfaction
Time frame: 3 months after pellet insertion of the gestrinone or placebo pellet
Median of the participant satisfaction scale (ranging from 1 to 5, from very satisfied to very dissatisfied)
Pelvic pain intensity
Time frame: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
Median of pelvic pain and dysmenorrhea intensity assessed by the NPRS scale, from 0 to 10 points where 10 points indicates worst pain
Use of pain relief medication
Time frame: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
Number of participants who used pain relief medication (analgesics and anti-inflammatories)
Patient-reported Quality of Life
Time frame: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
Number of participants with changes in the 36-Item Short Form Health Survey (SF-36). SF-36 is a patient-reported outcome (PRO) measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health
Endometriosis Health Profile
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Number of participants with changes in the Endometriosis Health Profile Questionnaire (EHP-30). The Endometriosis Health Profile Questionnaire is a Health Related Quality of Life (HRQoL) patient self-report PRO, used to measure the wide range of effects that endometriosis can have on women's lives: pain, control and powerlessness, social support, emotional well-being, and self-image, range from 0-100, higher values indicate worse health status
Uterine Bleeding Pattern
Time frame: daily for 3 months after pellet insertion of the gestrinone or placebo pellet
Changes in uterine bleeding pattern (spotting/bleeding)
Serum total gestrinone concentration
Time frame: pre-insertion of the pellet (baseline) and 24 hours; 7 days, 14 days , 21 days , 28 days , 56 days, 84 days, 112 days, 140 days and 168 days post-insertion
Multiple blood sample will be collected before pellet implantation and 24 hours; 7 days, 14 days , 21 days, 28 days, 56 days, 84 days, 112 days, 140 days and 168 days and will be determined by liquid chromatography (LC-MS/MS)
Area under the curve (AUC(0 ∞))
Time frame: pre-insertion of the pellet (baseline) and 24 hours; 7 days, 14 days , 21 days , 28 days , 56 days, 84 days, 112 days, 140 days and 168 days post-insertion
Multiple blood sample will be collected before pellet implantation and 24 hours; 7 days, 14 days , 21 days, 28 days, 56 days, 84 days, 112 days, 140 days and 168 days and will be determined by liquid chromatography (LC-MS/MS)
Maximum concentration (Cmax)
Time frame: pre-insertion of the pellet (baseline) and 24 hours; 7 days, 14 days , 21 days , 28 days , 56 days, 84 days, 112 days, 140 days and 168 days post-insertion
Multiple blood sample will be collected before pellet implantation and 24 hours; 7 days, 14 days , 21 days, 28 days, 56 days, 84 days, 112 days, 140 days and 168 days and will be determined by liquid chromatography (LC-MS/MS)
Time to reach maximum concentration (tmax)
Time frame: pre-insertion of the pellet (baseline) and 24 hours; 7 days, 14 days , 21 days , 28 days , 56 days, 84 days, 112 days, 140 days and 168 days post-insertion
Multiple blood sample will be collected before pellet implantation and 24 hours; 7 days, 14 days , 21 days, 28 days, 56 days, 84 days, 112 days, 140 days and 168 days and will be determined by liquid chromatography (LC-MS/MS)
Half Life (t1/2)
Time frame: pre-insertion of the pellet (baseline) and 24 hours; 7 days, 14 days , 21 days , 28 days , 56 days, 84 days, 112 days, 140 days and 168 days post-insertion
Multiple blood sample will be collected before pellet implantation and 24 hours; 7 days, 14 days , 21 days, 28 days, 56 days, 84 days, 112 days, 140 days and 168 days and will be determined by liquid chromatography (LC-MS/MS)
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Science Valley Research InstituteSão Paulo, São Paulo, BrazilStatus unknown
Study team and timeline
- Lead sponsor
- Science Valley Research Institute
- Study start
- Feb 13, 2023 Actual
- Primary completion
- May 21, 2025 Actual
- Study completion
- Oct 31, 2025 Actual
- First posted
- Oct 7, 2022 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Investigate the Safety and Exploratory Efficacy of a Subdermal Implant-bioabsorbable Gestrinone Pellet for Pelvic Pain Secondary to Endometriosis Treatment
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026