Letrozole Dose Increments in PCOS Patients Resistant to Letrozole

NCT06403488 | Completed Phase 3

• 1 other identifier: Letrozole dose increments
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

Objectives: To study the effect of Letrozole dose increments on ovulation rate and endometrial thickness as a primary outcomes in patients with polycystic ovary syndrome who previously resistant to letrazole conventional dose, and chemical and clinical pregnancy considered as secondary outcomes.

Conditions

Polycystic Ovary Syndrome

Keywords

Letrozole; ovulation; PCOS

Outcome Measures

Primary Outcomes (2)

• ovulation rate

  the follicular size by trans-vaginal ultrasound reached more than 18 mm

  1 month

• endometrial thickness

  assessed by trans-vaginal ultrasound

  1 cycle (1month)

Secondary Outcomes (1)

• pregnancy rate

  1 month

Study Arms (2)

femara 1x3

EXPERIMENTAL

Femara 2.5 mg (Novartis pharma ) 3 tablets per day starting from the second day of the menstrual cycle for 5 days

Drug: Letrozole 2.5mg

femara 2x2

EXPERIMENTAL

(Femara 2.5 mg (Novartis pharma )2 tablets twice daily for 5 days starting from the second day of the cycle

Drug: Letrozole 2.5mg

Interventions

Letrozole 2.5mg DRUG

specific aromatase inhibitor

Also known as: femara

femara 1x3; femara 2x2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normal semen analysis of their male partner
• Diagnosis of PCOS based on a modified form of the Rotterdam criteria

You may not qualify if:

• Any contraindications for pregnancy
• patients received other medications for ovulation induction such as metformin or clomiphene citrate and gonadotropins concomitantly
• hyperprolactinemia
• abnormal thyroid functions
• multiple uterine fibroids

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Beni-suef university Hospital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: October 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)