Effects of Alpha-acid Lipoic in PCOS Women

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of 6 Months of Alpha-Lipoic Acid Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02666170
• Other study ID #: Alpha-Lipoic Acid 2016
• Status: Not yet recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: January 26, 2016
• Start date: January 2016

Study information

• Verified date: January 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacred Heart
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

• pregnancy

• past history of cardiovascular diseases

• diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)

• hypertension

• significant liver or renal impairment

• other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal)

• neoplasms.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Alpha-lipoic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cycles in six months of therapy		6 months	No
Secondary	Hirsutism score	Ferriman-Gallwey score	6 months	No
Secondary	Insulin levels		6 months	No
Secondary	androstenedione levels		6 months	No
Secondary	testosterone levels		6 months	No
Secondary	free androgen index		6 months	No
Secondary	total cholesterol		6 months	No
Secondary	LDL-cholesterol		6 months	No
Secondary	tryglycerides levels		6 months	No
Secondary	DHEAS levels		6 months	No
Secondary	AMH levels		6 months	No