Clinical trial · Interventional
Aromatase Inhibitors for Treatment of Uterine Leiomyomas
Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to recruit patients
Summary
Brief summary (as posted)
Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Symptomatic or Large Uterine Fibroids | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole (aromatase inhibitor) | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- aromatase inhibitors: Letrozole
- description
- All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.
- interventionNames
- Drug: Letrozole (aromatase inhibitor)
Primary outcomes (1)
- measure
- The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.
- timeFrame
- 2 months and 6 months following treatment
Secondary outcomes (4)
- measure
- Improvement in symptoms
- timeFrame
- 2 and 6 months following treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms Exclusion Criteria: 1. Women \<50 years of age 2. Postmenopausal women 3. Women with impaired renal function 4. Oral treatment with any type of estrogen or progesterone more recently than 1 month 5. History of venous thromboembolism 6. Any contraindication for Magnetic Resonance Imaging (MRI)
References
Publications (0)
Data not yet available