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Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women
Plain-language guide to NCT01987804: phase 2 randomized trial of Oxytocin, 64 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01987804
- Phase
- phase 2
- Status
- completed
- Start
- 2012-01
- Completion (planned or actual)
- 2012-12
- Participants
- 64 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Vaginal Atrophy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Oxytocin.
N=16 patients are administrated placebo vaginally.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 64 actual participants took part.
It was open to women only aged from 40 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline. \> 40 years of age. Atrophic mucosa according to the investigator's assessment. Signed Informed Consent.
The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: 1\. usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2012-01 with completion listed for 2012-12.
It ran at 1 site in Sweden.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example To investigate the safety and tolerability of topical Vagitocin treatment.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Oxytocin in 64 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
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.