Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome

• Status: Completed
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of triple drug cocktail (metformin, pioglitazone and acetyl L-Carnitine) therapy on metabolic, endocrine alterations and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Women diagnosed with PCOS, using criteria proposed in November 2015, by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and Androgen Excess and PCOS Society (AES) for PCOS should include two of the following three criteria: chronic an ovulation, hyperandrogenism (clinical/biologic), and polycystic ovaries. The investigators propose that PCOS women may have altered metabolic, endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Khyber Medical University Peshawar
• Treatments: Acetylcarnitine; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

1. Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome

2. Hirsutism or hyperandrogenism

3. Oligo or an-ovulation and or polycystic ovaries -

Exclusion Criteria:

1. Women with previous history of Cushing syndrome

2. Thyroid disorders

3. Hyperprolactinemia

4. Ovarian tumors

5. Congenital adrenal hyperplasia androgen-producing tumors,

6. History of seizures

7. Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine,

8. Pregnancy or using contraceptive medications,

9. Patients on hormonal therapy that alters the biochemical or hormonal profile