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L-carnitine and Metformin in Obese PCOS Women.
Plain-language guide to NCT03108963: phase 2 randomized trial of L-Carnitine, pcos, 280 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03108963
- Phase
- phase 2
- Status
- completed
- Start
- 2017-01
- Completion (planned or actual)
- 2018-03
- Participants
- 280 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- PCOS
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around L-Carnitine for pcos.
L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial.
It had two arms (groups): L-carnitine and Metformin (experimental) and placebo (active comparator).
L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate.
Placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate.
The registry classes the interventions as drug.
More on the Plan
The trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.
Who Took Part
Enrollment: 280 planned participants were the target.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: no medical disorders; no hormonal treatment in the previous 3 months.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
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.
Neither the pcos participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2017-01 with completion listed for 2018-03.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): pregnancy rate (time frame: 3 momths).
It also tracked 4 secondary outcomes, for example ovulation rate, abortion rate, insulin resistance and lipid metabolism.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of L-Carnitine in 280 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.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.