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N-Acetylcysteine and L-carnitine in Pcos
Plain-language guide to NCT03164421: phase 2 randomized trial of L-Carnitine, pcos, 164 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03164421
- Phase
- phase 2
- Status
- completed
- Start
- 2017-01
- Completion (planned or actual)
- 2018-06
- Participants
- 164 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- PCOS
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested L-Carnitine for pcos.
N-Acetylcysteine and L-carnitine were used in pcos patients.
It had two arms (groups): N-Acetylcysteine (experimental) and L-carnitine (active comparator).
N-Acetylcysteine used by clomiphene resistant pcos women.
L-carnitine used by clomiphene resistant pcos women.
The registry classes the interventions as drug.
More on the Plan
N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect the hormonal and metabolic effect.
Who Took Part
164 actual participants took part.
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 2 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.
Groups ran in parallel: each of the pcos participants stayed in one arm throughout.
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 2018-06.
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 2 secondary outcomes, for example ovulation rate and abortion rate.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of L-Carnitine in 164 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.