NCT04113889: PCOS

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

Completed Phase 2 Last updated 5 February 2020

What this trial tests

Phase 2 trial testing Metformin (1000 mg daily), Pioglitazone (30 mg daily), Acetyl-L-carnitine (3 gm daily) in PCOS in 147 participants. Completed in 30 January 2020.

Timeline

15 October 2019

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	Khyber Medical University Peshawar
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	147
Start date	15 October 2019
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	1 location across Pakistan

Drugs / interventions tested

• Metformin (1000 mg daily), Pioglitazone (30 mg daily), Acetyl-L-carnitine (3 gm daily) — full drug profile →
• Metformin, pioglitazone and placebo — full drug profile →

Conditions studied

• PCOS — all drugs for PCOS →

Sponsor

Khyber Medical University Peshawar

Who can join

Adults 15 to 45, female only, with PCOS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways and targeted therapeutic strategies for polycystic ovary syndrome.
   Wang K, Li Y. · · 2023 · cited 35× · PMID 37929034 · DOI 10.3389/fendo.2023.1191759
2. Acetyl-L-Carnitine Ameliorates Metabolic and Endocrine Alterations in Women with PCOS: A Double-Blind Randomized Clinical Trial.
   Tauqir S, Israr M, Rauf B, Malik MO, et al · · 2021 · cited 19× · PMID 34047916 · DOI 10.1007/s12325-021-01789-5