Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
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| ClinicalTrials.gov Identifier: NCT03135301 |
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Recruitment Status :
Recruiting
First Posted : May 1, 2017
Last Update Posted : January 31, 2023
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Sponsor:
Assiut University
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infertility, Female | Drug: letrozole plus metformin Drug: letrozole | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Combined Letrozole-metformin in Comparison With Letrozole Only in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome |
| Actual Study Start Date : | June 20, 2017 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | March 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Polycystic ovary syndrome
| Arm | Intervention/treatment |
|---|---|
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Experimental: letrozole plus metformin
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
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Drug: letrozole plus metformin
letrozole 5 milligram tablets plus metformin 850 milligram tablets |
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Active Comparator: letrozole
5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding
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Drug: letrozole
letrozole 5 milligram tablets |
Primary Outcome Measures :
- The ovulation rate [ Time Frame: 14 days ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135301
Locations
| Egypt | |
| Assiut Faculty of Medicine | Recruiting |
| Assiut, Egypt | |
| Contact: Ahmed Abbas, MD 0100 bmr90@hotmail.com | |
Sponsors and Collaborators
Assiut University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ahmed Mohamed Abbas, Dr, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03135301 |
| Other Study ID Numbers: |
LET |
| First Posted: | May 1, 2017 Key Record Dates |
| Last Update Posted: | January 31, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome Infertility Infertility, Female Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Metformin |
Letrozole Hypoglycemic Agents Physiological Effects of Drugs Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |