Uterine BleedingMySaturnNCT06953076
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
An observational study of Uterine Bleeding and Uterine Leiomyomas, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Uterine fibroids are benign tumors originating from the uterine muscle, affecting up to 70% of women by their 50s. Risk factors include African descent, nulliparity, obesity, and diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage
- What is being tested?
- Relugolix/estradiol/norethisterone acetate
- Type of treatment
- Pill or oral medicine
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2025to 2 May 2027
- Phase
- Observational
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone
Who may be able to join
- Age ≥ 18 years.
- Pre-menopausal status.
- Ultrasound diagnosis of benign myometrial lesion.
- Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia/metrorrhagia).
- Availability of ultrasound images in digital format.
Who cannot join
- Patient refusal.
- Age < 18 years.
- Postmenopausal women.
- Myometrial lesion ≤ 10 mm.
- Myometrial formation suspected of malignancy on ultrasound (e.g., STUMP - Uterine Leiomyosarcoma).
- Asymptomatic patients with uterine fibromatosis.
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- Personal history of malignant or premalignant uterine neoplasia (e.g., STUMPs, leiomyosarcoma, atypical endometrial hyperplasia, endometrial carcinoma, cervical carcinoma).
- Patients with ovarian pathology.
- Patients currently undergoing treatment for another malignancy.
- Patients lacking available digital ultrasound images or whose image quality is insufficient to adequately characterize the target lesion's ultrasound features
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Roma, 00168
Daniela Romualdi, +393392996830, daniela.romualdi@policlinicogemelli.it
Daniela Romualdi
About this study
Official title: MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study
Uterine fibroids are benign tumors originating from the uterine muscle, affecting up to 70% of women by their 50s. Risk factors include African descent, nulliparity, obesity, and diabetes. While many fibroids are asymptomatic, 25-50% of affected women experience symptoms like heavy menstrual bleeding, pelvic pain, and pressure-related issues. Accurate diagnosis and differentiation from rare malignant tumors (e.g., uterine sarcomas) remain challenging, particularly before surgery.
Ultrasound is the first-line tool for evaluating fibroids, with specific features (e.g., shape, vascularity) helping distinguish benign from suspicious lesions. The MUSA guidelines standardize ultrasound terminology for myometrial assessments. Current treatment options vary based on symptoms and malignancy risk. Among pharmacologic options, the combination of relugolix, estradiol, and norethisterone has shown efficacy in reducing bleeding and pain in symptomatic fibroids, with a favorable safety profile. However, its impact on fibroid morphology and ultrasound appearance is not yet well understood.
Read the detailed description
Uterine fibroids are the most common benign tumors in women of reproductive age, affecting up to 70% of women in their 40s and 50s. While often asymptomatic, around 25-50% experience symptoms such as heavy menstrual bleeding, pelvic pain, and pressure-related issues. The severity depends on the number, size, and location of the fibroids.
Though most fibroids are benign, a small risk exists for malignant uterine tumors (e.g., leiomyosarcomas, STUMPs). Diagnosing these malignancies preoperatively remains a challenge due to the lack of reliable imaging markers. Ultrasound is the first-line diagnostic tool, guided by MUSA criteria, but further prospective data are needed to improve risk stratification.
The combination of Relugolix, Estradiol, and Norethisterone (Ryeqo®) is an effective medical treatment for symptomatic fibroids, especially in premenopausal women. It reduces bleeding while minimizing side effects of estrogen deprivation. Over 70% of women in clinical trials have shown significant improvement within 24 weeks. However, its effect on fibroid morphology and ultrasound features remains unclear.
The MySaturn Study aims to assess whether this therapy modifies the ultrasound appearance of myometrial lesions over 12 months. The study also tracks symptom changes and adverse events. It involves 111 premenopausal women in a monocentric ambispective observational design, combining retrospective and prospective data from July 1, 2023. The study spans 3 years (2 years of enrollment + 1 year follow-up) and uses routine clinical, laboratory, and imaging data for analysis.
Adverse events will be monitored and reported in accordance with national pharmacovigilance regulations.
- Being tested
- Relugolix/estradiol/norethisterone acetate
- Keywords
- myomas, uterine bleeding, fibroids, relugolix, ormonal therapy, smooth muscle cells tumor
- Medical subject headings
- Uterine Hemorrhage, Myofibroma, Uterine Neoplasms, Myoma, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relugolix/estradiol/norethisterone acetateDrug
Also called Ryeqo
Oral therapy administered to patients with symptomatic uterine fibroids presenting with abnormal uterine bleeding
| Study group | Role | What they receive |
|---|---|---|
| Uterine fibroids symptomatic for abnormal uterine bleeding | Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone Receives: Drug: Relugolix/estradiol/norethisterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone
Modifications in the volume of the myometrial lesion
Measured: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
To observe the ultrasound features of myometrial lesions during treatment with relugolix/estradiol/norethisterone
- 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
Measured: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
Secondary outcomes (1)
Description of the clinical characteristics of the study population during treatment with relugolix/estradiol/norethisterone.
- 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
Measured: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start2 May 2025
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Uterine BleedingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROMUALDI DANIELA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Daniela Romualdi, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953076
- Sponsor's protocol ID
- 7427
- Acronym
- MySaturn
- Status last verified
- Aug 2025
- First submitted
- 21 Apr 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Education and Practical Standards Committee, European Federation of Societies for Ultrasound in Medicine and Biology. Minimum training recommendations for the practice of medical ultrasound. Ultraschall Med. 2006 Feb;27(1):79-105. doi: 10.1055/s-2006-933605. No abstract available.
PubMed 16508866Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.
PubMed 33596357Al-Hendy A, Venturella R, Arjona Ferreira JC, Li Y, Soulban G, Wagman RB, Lukes AS. LIBERTY randomized withdrawal study: relugolix combination therapy for heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2023 Dec;229(6):662.e1-662.e25. doi: 10.1016/j.ajog.2023.08.030. Epub 2023 Sep 2.
PubMed 37666383Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. Obstet Gynecol. 2022 Dec 1;140(6):920-930. doi: 10.1097/AOG.0000000000004988. Epub 2022 Nov 2.
PubMed 36357960De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95(2):100-107.
PubMed 28084714Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10.
PubMed 25652685Ciccarone F, Biscione A, Robba E, Pasciuto T, Giannarelli D, Gui B, Manfredi R, Ferrandina G, Romualdi D, Moro F, Zannoni GF, Lorusso D, Scambia G, Testa AC. A clinical ultrasound algorithm to identify uterine sarcoma and smooth muscle tumors of uncertain malignant potential in patients with myometrial lesions: the MYometrial Lesion UltrasouNd And mRi study. Am J Obstet Gynecol. 2025 Jan;232(1):108.e1-108.e22. doi: 10.1016/j.ajog.2024.07.027. Epub 2024 Jul 30.
PubMed 39084498Stewart EA, et al. Uterine fibroids. Lancet. 2022; 400(10352):1341-1351