EndometriosisPhase 2GLADENCT05570786
Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment
A Phase 2 study testing Gestrinone in people with Endometriosis and Pelvic Pain, run by Science Valley Research Institute at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- Gestrinone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Feb 2023to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willingness to provide informed consent
- Woman aged between 18 and 50 years
- Body weight between 50 ± 5 kg and 90 ± 5 kg
- Pelvic pain secondary to endometriosis surgically treated with refractory symptoms, independent of pain intensity
- Endometriosis documented by biopsies (histopathological examination)
- Last endometriosis surgery at least 3 months before randomization
Show all 9Show fewer
- Not planning to become pregnant within 12 months after the screening visit or be surgically sterilized
- 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
- Agreement not to use other hormones (estrogens, androgens and progestins) in any pharmaceutical form during the study
Who cannot join
- 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
- Suspected or confirmed diagnosis of immunodeficiency based on medical history and/or physical or laboratory examination
- 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
- Personal history of thromboembolic events
- Use anticoagulant medication
- Contraindication to the use of hormonal contraceptives
Show all 27Show fewer
- Suspected or confirmed pregnancy
- Breastfeeding
- Current or recurrent pelvic inflammatory disease or other conditions that increase the risk of pelvic infections
- Postpartum endometritis or septic miscarriage in the last 3 months
- Abnormal uterine bleeding of unknown etiology
- Congenital or acquired uterine anomalies, including fibroids (leiomyomas or fibromas) that cause distortion of the uterine cavity
- Uterine or cervical malignancy
- Suspected or confirmed diagnosis of estrogen-dependent neoplasm, including breast cancer
- Cervicitis or vaginitis, including bacterial vaginosis or another uncontrolled lower urinary tract infection
- Cervical dysplasia
- Active liver disease or dysfunction
- Benign or malignant liver tumors
- Allergy or intolerance to levonorgestrel, gestrinone or any other ingredient or component of the Kyleena® formulation or hormonal pellets
- Previously inserted intrauterine device or levonorgestrel-releasing intrauterine system that has not been removed
- History of recent trophoblastic disease and continued high HCG levels
- Bacterial endocarditis
- 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
- Diagnosis of polycystic ovary syndrome
- Participation in another pharmacotherapeutic or investigational medical device study within 30 days prior to the start of study treatment
- Tobacco Use
- Use of testosterone-derived hormones and analogues in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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 detailed description
This is a multicenter, prospective, randomized, double-blind and placebo-controlled study to evaluate the safety and tolerability of of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis. The exploratory aim is to compare the use of a gestrinone pellet with a placebo pellet in the results of participant satisfaction, change in pelvic pain intensity, use of rescue pain medication, quality of life, sexual function, and work activity. PK profile of the gestrinone pellet will be monitored. 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 treatment-related serious adverse events (SAEs) accumulated within 6 months of pellet insertion and collected through spontaneous reporting and/or clinical findings.
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- Gestrinone, Placebo
- Keywords
- Hormone Pellet Therapy, Implantable Hormone Pellets, Endometriosis, Pelvic pain
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GestrinoneDrug
The intradermal gestrinone/placebo pellet will be inserted on the same day as the levonorgestrel intrauterine hormonal device (Kyleena®)
PlaceboDrug
Subdermal implant-bioabsorbable placebo pellet (cholesterol)
| Study group | Role | What they receive |
|---|---|---|
| Gestrinone | Experimental | Subdermal implant-bioabsorbable gestrinone pellet (85 mg) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method Receives: Drug: Gestrinone |
| Placebo | Placebo comparator | Subdermal implant-bioabsorbable placebo pellet (cholesterol) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Proportion of patients who dhave SAEs: 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.
The treatment-related SAEs were considered for the primary safety outcome.
Measured: From randomization to the end of study on Day 180
Secondary outcomes (7)
Androgenization
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
Measured: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
Plasma concentration of steroid hormones
plasma concentration of total testosterone, free testosterone, and SHBG
Measured: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Lipid profile
Serum levels of total cholesterol, HDL-C, VLDL-C, and triglycerides
Measured: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Uterine Bleeding Pattern
Changes in uterine bleeding pattern (spotting/bleeding)
Measured: daily for 3 months after pellet insertion of the gestrinone or placebo pellet
Hematological disorders
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)
Measured: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Hepatic adverse events
Number of participants with increased ALT or AST > 3 times ULN or baseline, alterations in ALP levels suspected hepatocellular or cholestatic hepatotoxicity
Measured: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Renal adverse events
Number of participants with increased serum creatinine ≥ 1.5 times ULN or baseline; clinically significant increase in serum urea
Measured: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start13 Feb 2023
- Primary completion21 May 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biós Farmacêutica
- Responsible party
- Sponsor
- Investigators
- Eduardo Ramacciotti, MD, PhD, Study chair, Science Valley Research InstituteAndré Luiz M Oliveira, MD, MHS, Principal investigator, Science Valley Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570786
- Sponsor's protocol ID
- GLADE
- Acronym
- GLADE
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.
PubMed 35350465Coutinho EM. Treatment of endometriosis with gestrinone (R-2323), a synthetic antiestrogen, antiprogesterone. Am J Obstet Gynecol. 1982 Dec 15;144(8):895-8. doi: 10.1016/0002-9378(82)90180-6.
PubMed 6216812Venturini PL, Bertolini S, Brunenghi MC, Daga A, Fasce V, Marcenaro A, Cimato M, De Cecco L. Endocrine, metabolic, and clinical effects of gestrinone in women with endometriosis. Fertil Steril. 1989 Oct;52(4):589-95. doi: 10.1016/s0015-0282(16)60969-x.
PubMed 2806598Gestrinone versus a gonadotropin-releasing hormone agonist for the treatment of pelvic pain associated with endometriosis: a multicenter, randomized, double-blind study. Gestrinone Italian Study Group. Fertil Steril. 1996 Dec;66(6):911-9. doi: 10.1016/s0015-0282(16)58682-8.
PubMed 8941054Devogelaer JP, Nagant de Deuxchaisnes C, Donnez J. Endometriosis. Lancet. 1993 Jan 30;341(8840):312-3. doi: 10.1016/0140-6736(93)92673-h. No abstract available.
PubMed 8093956Malavasi A, Ribeiro CM, Agati LB, Silva Filho A, Berger C, Schor E, Comin A, Bezerra Neto EJ, Oliveira TH, Caldas PR, Lopes F, Westphalen N, Vieira F, Socca EAR, Komar D, Ramacciotti E. Rationale and design of the GLADE study: a randomized, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of gestrinone subdermal bioabsorbable pellet in endometriosis-related pelvic pain. Ann Med. 2025 Dec;57(1):2527352. doi: 10.1080/07853890.2025.2527352. Epub 2025 Jul 11.
PubMed 40641309
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05570786
- Acronym / sponsor ID
- GLADE / GLADE
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- Hormone Pellet Therapy, Implantable Hormone Pellets, Endometriosis, Pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Science Valley Research InstituteUniversity, hospital or other
- Collaborators
- Biós Farmacêutica
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, prospective, randomized, double-blind and placebo-controlled study to evaluate the safety and tolerability of of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis. The exploratory aim is to compare the use of a gestrinone pellet with a placebo pellet in the results of participant satisfaction, change in pelvic pain intensity, use of rescue pain medication, quality of life, sexual function, and work activity. PK profile of the gestrinone pellet will be monitored. 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 treatment-related serious adverse events (SAEs) accumulated within 6 months of pellet insertion and collected through spontaneous reporting and/or clinical findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestrinone | Experimental | Drug: GestrinoneSubdermal implant-bioabsorbable gestrinone pellet (85 mg) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method |
| Placebo | Placebo comparator | Drug: PlaceboSubdermal implant-bioabsorbable placebo pellet (cholesterol) All patients will undergo insertion of an intrauterine system of levonorgestrel release (Kyleena®) as a contraceptive method |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willingness to provide informed consent
- Woman aged between 18 and 50 years
- Body weight between 50 ± 5 kg and 90 ± 5 kg
- Pelvic pain secondary to endometriosis surgically treated with refractory symptoms, independent of pain intensity
- Endometriosis documented by biopsies (histopathological examination)
Key exclusion criteria (27 listed)
- 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
- Suspected or confirmed diagnosis of immunodeficiency based on medical history and/or physical or laboratory examination
- 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
- Personal history of thromboembolic events
- Use anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GestrinoneThe intradermal gestrinone/placebo pellet will be inserted on the same day as the levonorgestrel intrauterine hormonal device (Kyleena®) | Drug | Gestrinone |
| PlaceboSubdermal implant-bioabsorbable placebo pellet (cholesterol) | Drug | Placebo |
Primary outcome
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 Day 180
Proportion of patients who dhave SAEs: 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. The treatment-related SAEs were considered for the primary safety outcome.
7 secondary outcomes
Androgenization
Time frame: pre-insertion assessment of the pellet (baseline), 3 and 6 months after insertion of the gestrinone or placebo pellet
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
Lipid profile
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Uterine Bleeding Pattern
Time frame: daily for 3 months after pellet insertion of the gestrinone or placebo pellet
Hematological disorders
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Hepatic adverse events
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Renal adverse events
Time frame: pre-insertion of the pellet (baseline) and 3 months after pellet insertion of the gestrinone or placebo pellet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 35350465Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.
- Background: PubMed 6216812Coutinho EM. Treatment of endometriosis with gestrinone (R-2323), a synthetic antiestrogen, antiprogesterone. Am J Obstet Gynecol. 1982 Dec 15;144(8):895-8. doi: 10.1016/0002-9378(82)90180-6.
- Background: PubMed 2806598Venturini PL, Bertolini S, Brunenghi MC, Daga A, Fasce V, Marcenaro A, Cimato M, De Cecco L. Endocrine, metabolic, and clinical effects of gestrinone in women with endometriosis. Fertil Steril. 1989 Oct;52(4):589-95. doi: 10.1016/s0015-0282(16)60969-x.
- Background: PubMed 8941054Gestrinone versus a gonadotropin-releasing hormone agonist for the treatment of pelvic pain associated with endometriosis: a multicenter, randomized, double-blind study. Gestrinone Italian Study Group. Fertil Steril. 1996 Dec;66(6):911-9. doi: 10.1016/s0015-0282(16)58682-8.
- Background: PubMed 8093956Devogelaer JP, Nagant de Deuxchaisnes C, Donnez J. Endometriosis. Lancet. 1993 Jan 30;341(8840):312-3. doi: 10.1016/0140-6736(93)92673-h. No abstract available.
- Background: PubMed 40641309Malavasi A, Ribeiro CM, Agati LB, Silva Filho A, Berger C, Schor E, Comin A, Bezerra Neto EJ, Oliveira TH, Caldas PR, Lopes F, Westphalen N, Vieira F, Socca EAR, Komar D, Ramacciotti E. Rationale and design of the GLADE study: a randomized, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of gestrinone subdermal bioabsorbable pellet in endometriosis-related pelvic pain. Ann Med. 2025 Dec;57(1):2527352. doi: 10.1080/07853890.2025.2527352. Epub 2025 Jul 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Ramacciotti, MD, PhD study chair
Science Valley Research Institute
André Luiz M Oliveira, MD, MHS principal investigator
Science Valley Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gestrinone in people with Endometriosis and Pelvic Pain, run by Science Valley Research Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570786, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.