Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation

NCT07589075 | Completed Phase 4 DMC

• 1 other identifier: IORG2226240
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.

Conditions

Induction of Ovulation

Outcome Measures

Primary Outcomes (2)

• Ovulation rate

  percentage of ovulatory cycles

  "through study completion, an average of 1 year".

• Pregnancy rate

  when an intrauterine gestational sac is seen and presence of a fetal heartbeat)

  "through study completion, an average of 1 year".

Secondary Outcomes (3)

• Serum progesterone

  "through study completion, an average of 1 year".

• Endometrial thickness

  "through study completion, an average of 1 year".

• Weight

  "through study completion, an average of 1 year".

Study Arms (4)

"metformin"

EXPERIMENTAL

will take Metformin 1000mg as adjuvant therapy

Drug: Metformin 1000 mg; Drug: Letrozole 2.5Mg Tablet

"Dapagliflozin"

EXPERIMENTAL

will take Dapagliflozin 10mg as adjuvant therapy

Drug: Dapagliflozin 10 mg; Drug: Letrozole 2.5Mg Tablet

"Dapagliflozin-Metformin"

EXPERIMENTAL

will take combined Dapagliflozin-Metformin 5/1000 as adjuvant therapy

Drug: Combined Dapagliflozin-Metformin 5/1000mg; Drug: Letrozole 2.5Mg Tablet

"control"

OTHER

will take letrozole 2.5mg the no adjuvant therapy

Drug: Letrozole 2.5Mg Tablet

Interventions

Metformin 1000 mg DRUG

will take Metformin 1000 mg once daily with a main meal and started one month before initiation of the first cycle of induction.

"metformin"

Dapagliflozin 10 mg DRUG

will take Dapagliflozin 10mg once daily with a main meal and started one month before initiation of the first cycle of induction.

"Dapagliflozin"

Combined Dapagliflozin-Metformin 5/1000mg DRUG

will take Combined Dapagliflozin-Metformin 5/1000mg once daily with a main meal and started one month before initiation of the first cycle of induction.

"Dapagliflozin-Metformin"

Letrozole 2.5Mg Tablet DRUG

will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.

"Dapagliflozin"; "Dapagliflozin-Metformin"; "control"; "metformin"

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal women aged 20-40 with primary or secondary infertility and PCOS which render them unable to become pregnant. Diagnosis of PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met: oilgo and/or anovulation (infrequent or no ovulation), clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels or polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).

You may not qualify if:

• Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
• Persistent hyperprolactinemia, thyroid dysfunction defined as TSH \< 0.2 mIU/ML or \>5.5 mIU/mL) or patients with menopausal levels of FSH (\> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
• Liver disease is defined as AST or ALT \> 2 times normal or total bilirubin \>2.5 mg/dL, kidney disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL or significant anemia defined as Hemoglobin \< 10 mg/dL.
• Women with Type I or II diabetes mellitus who are poorly controlled (defined as a HA1c level \> 7.0%).
• Untreated poorly controlled hypertension is defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
• History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
• Women who have undergone a bariatric surgery procedure in the recent past (\<12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
• Presence of any urinary symptom such as frequency, urgency, or bloody micturition.
• In case of metabolic acidosis, osteoporosis, endometrial hyperplasia, or endometrial neoplasia.
• Women who had gonadotropin induction, ovarian drilling before or women with hypergonadotropic hypogonadism or functional ovarian cysts (\> 5cm).
• Criteria of IVF/ICSI as poor Response, no Eggs or ectopic pregnancy. Women who receive antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas are likely to confound the effects of study medication or who are currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
• Concomitant use of medication that could interfere with the absorption, metabolism, and excretion of drugs involved in the study as the use of Furosemide, cimetidine increase metformin concentration and nifedipine enhances the absorption of metformin.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Gynecology and Reproductive department in Beni-Suef University Hospital

Banī Suwayf, 62517, Egypt

Location

MeSH Terms

Interventions

Metformin; dapagliflozin; Letrozole; Tablets

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: randomized control trial

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: May 15, 2026
• Study Start: October 20, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 30, 2025
• Last Updated: May 15, 2026

Record last verified: 2025-08

Locations

EG (1)