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A Study Comparing Letrozole and Methotrexate for the Treatment of Unruptured Ectopic Pregnancy

A Randomized Controlled Trial Comparing Letrozole and Methotrexate for the Treatment of Unruptured Ectopic Pregnancy

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250117002
Enrollment
80
Registered
2025-01-17
Start date
2025-03-01
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

Participants who diagnosed with unruptured ectopic pregnancy. Unruptured ectopic pregnancy, Letrozole, Methotrexate

Interventions

Participants will be randomly allocated using block randomization, Those assigned to the study group receive Letrozel 10 mg per day orally for 10 days.,The participants in this group will be treated
Experimental Drug,Active Comparator Drug
Letrozle group,Methotrexate group

Sponsors

Buri Ram Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 - 40 years. 2. Clinically diagnosed with unruptured ectopic pregnancy confirmed by ultrasound. 3. Hemodynamically stable. 3 Serum hCG levels between 1,000 and 3,000 IU/L. 4. No evidence of intrauterine pregnancy or fetal heartbeat on ultrasound.

Exclusion criteria

Exclusion criteria: 1. Evidence of ruptured ectopic pregnancy or hemodynamic instability. 2. Serum hCG > 3,000 IU/L. 3. Known contraindications to letrozole or methotrexate. 4. Severe hepatic or renal dysfunction. 5. Presence of other significant medical conditions that may interfere with treatment.

Design outcomes

Primary

MeasureTime frame
Sucess of medical treatment At 8 weeks after end of the intervention. Blood HCG less than 5 IU/L

Secondary

MeasureTime frame
Time to resolution HCG 8 weeks Mean,Adverse events: leukopenia, hepatitis, ulcerative stomatitis, nausea, abdominal distress ect Three months after treatment Number

Countries

Thailand

Contacts

Public ContactSiriphen Uengphinitphong

Buri Ram

mail2siriphen@gmail.com044625091

Outcome results

None listed

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