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

What Was Tested

The trial (phase 2) is built around L-Carnitine for pcos.

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.

It had two arms (groups): Combination therapy group (active comparator) and Standard therapy group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The three main features of the syndrome are polycystic ovaries, high levels of androgen in blood and chronic an-ovulation/oligo-an ovulation (2).

Women with PCOS have a greater risk of developing hyperinsulinemia and insulin resistance (3).

PCOS may lead to insulin resistance and dyslipidemia (3).

Metformin belongs to a family of drugs called the biguanides, currently used as an antihyperglycemic drug for treatment of type II diabetes mellitus (4).

Who Took Part

The registry lists 147 actual participants took part.

It was open to women only aged from 15 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Hirsutism or hyperandrogenism. Oligo or an-ovulation and or polycystic ovaries -.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: women with previous history of cushing syndrome; thyroid disorders; ovarian tumors.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The pcos participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2019-10-15 with completion listed for 2020-01-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Insulin resistance (time frame: 3 months). Hypoadiponectinemia (time frame: 3 months). Ovary volume (time frame: 3 months).

It also tracked 5 secondary outcomes, for example Body fat analysis, Hirsutism, Menstrual irregularities, Androgenic Alopecia and Pregnancy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 147 people with pcos.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, PCOS research.