A study to compare the beneficial effects of empagliflozin to metformin in patients having polycystic ovary syndrome

Phase 1

Conditions: Polycystic ovary syndrome
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2016-004435-20-GB

Lead Sponsor: Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

1) Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria.
2) Presence of both irregular periods and biochemical hyperandrogenaemia
3) Body mass index =25
4) Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing’s disease and androgen-secreting tumours will be excluded by appropriate tests.
2) Any concurrent illness including type 2 diabetes.
3) Subjects who are on any of the following medications within 3 months of recruitment:
• Metformin or other insulin-sensitizing medications (e.g., pioglitazone )
• Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.)
• Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
• Clomiphene citrate or estrogen modulators such as letrozole
• GnRH modulators such as leuprolide
• Minoxidil
4) Women planning to conceive.
5) eGFR<60
6) Hypersensitivity to lactose
7) Severe hepatic impairment (ALT >3 times ULN)
8) Women with history of recurrent urinary tract infections.
9) Haematocrit above the upper limit of normal range.
10) Have been involved in another medicinal trial (CTIMP) within the past four weeks.
11) Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.