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Efficacy and Safety of Three-Month Letrozole Therapy as a Preoperative Treatment in Premenopausal Women Undergoing Hysterectomy for Uterine Fibroids

Efficacy and Safety of Three-Month Letrozole Therapy as a Preoperative Treatment in Premenopausal Women Undergoing Hysterectomy for Uterine Fibroids : Prospective study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260621004
Enrollment
30
Registered
2026-06-21
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot flashes Myalgia Insomnia Headache Nausea and vomiting Alopecia Uterine fibroid Letrozole Premeopausal women Hysterectomy

Interventions

Letrozole 2.5 mg oral daily for 3 months
Experimental Drug
Letrozole

Sponsors

Bhumibol Adulyadej Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Premenopausal women aged 30 to 50 years 2. Women with one or more uterine fibroids, with the largest fibroid measuring at least 4 cm in diameter, confirmed by ultrasonography 3. Women with regular menstrual cycles 4. Women who have completed childbearing and do not desire future fertility 5. Women who are scheduled to undergo hysterectomy according to clinical indications 6. Women who voluntarily provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Women who have received hormonal therapy within the previous 3 months. 3. Women with uterine fibroids requiring urgent surgical intervention before completion of the 3-month treatment period. 4. Women with a history of osteoporosis or severe liver disease. 5. Women with a known diagnosis of malignancy. 6. Women with a known hypersensitivity or previous allergic reaction to letrozole

Design outcomes

Primary

MeasureTime frame
size of uterine fibroid 3 months Ultrasound for measure size of uterine fibroid

Secondary

MeasureTime frame
percentage change volume of uterine fibroid 3 months ultrasound for measure volume,symptoms from uterine fibroid 3 months PBAC, UFS-QOL,CTX, P1NP, Osteocalcin 3 months value,Estradiol, LH, FSH 3 months value

Countries

Thailand

Contacts

Public ContactSorawit Surawongsin

Department of Obstetrics and Gynecology, Bhumibol Adulyadej Hospital

bah.research27255@gmail.com025347255

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026