Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

NCT03135301 | Unknown Phase 3

• 1 other identifier: LET
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant acne, menstrual irregularity, acanthosis nigricans, and/or obesity

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• The ovulation rate

  14 days

Study Arms (2)

letrozole plus metformin

EXPERIMENTAL

5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding plus metformin will be started from the first day with a dose of 850 mg (1 tablet daily) and the dosage will be increased after 1 week up to 1,700 mg/day (2 tablets daily) and will be continued

Drug: letrozole plus metformin

letrozole

ACTIVE COMPARATOR

5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding

Drug: letrozole

Interventions

letrozole plus metformin DRUG

letrozole 5 milligram tablets plus metformin 850 milligram tablets

letrozole plus metformin

letrozole DRUG

letrozole 5 milligram tablets

letrozole

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• polycystic ovaries patients who had failed to become pregnant after 3 courses of 150 mg of clomiphene citrate (considered as clomiphene resistant),whereas the value of the above mentioned investigation are normal.

You may not qualify if:

• women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia.
• women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study.
• women with history of liver,kidney or cardiovascular disease.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

Related Publications (1)

• Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.

  PMID: 36165742 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Letrozole; Metformin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

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

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: Dr

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: June 20, 2017
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)