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Trial · NCT06953076

Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study

NCT06953076, Recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study. Trials, record NCT06953076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06953076

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
NCT number
NCT06953076
Status
Recruiting
Enrollment
111 participants, estimated
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage, Uterine Neoplasms
Interventions
Relugolix/estradiol/norethisterone acetate
First posted
2025-05-01
Last updated
2025-08-17

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTo observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisteroneat baseline, and after 3 months, 6 months, and 12 months from treatment initiationModifications in the volume of the myometrial lesion
PrimaryTo observe the ultrasound features of myometrial lesions during treatment with relugolix/estradiol/norethisteroneat baseline, and after 3 months, 6 months, and 12 months from treatment initiation
* Uterine volume * Outer contour: regular or irregular; * Echogenicity of the myometrial formation: mixed or homogeneous; * Presence of cystic areas; * Presence of acoustic shadows; * Vascularization of the lesions, expressed on a 1 to 4 ordinal scale; * "Cooked aspect" , if present
SecondaryDescription of the clinical characteristics of the study population during treatment with relugolix/estradiol/norethisterone.at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
* Effect on abnormal uterine bleeding, measured as the number of sanitary pads used during the cycle in patients who do not develop amenorrhea; * Hemoglobin, serum iron, and ferritin levels * Dyspareunia, assessed using NRS or VAS scales; * Chronic pelvic pain, assessed using NRS or VAS scales; * Compression-related symptoms; * Pollakiuria and dyschezia; * Dyspareunia

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16508866RESULTPubMed
25652685RESULTPubMed
28084714RESULTPubMed
33596357RESULTPubMed
36357960RESULTPubMed
37666383RESULTPubMed
39084498RESULTPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06953076

GET https://conductscience.org/api/trials/v1/NCT06953076/registered