CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
P-Dragees rosa Lichtensteinother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547661
NCT03547661N/ACompleted

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

Jens Gaab·interventional·Posted Jun 6, 2018·Updated Jun 5, 2025

In Brief

A clinical study evaluating P-Dragees rosa Lichtenstein for Premenstrual Syndrome. Completed, enrolled 150 participants across 1 site.

Detailed Summary

This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Participants of all groups will conclude a prospective PMS screening for one menstrual cycle. Thereafter, participants of both intervention groups will obtain an openly administered placebo intervention for six weeks. Participants of the treatment as usual group will have the chance to obtain the same open-label placebo intervention after study conduct. Diverse measures will be assessed by means of a PMS symptom diary and questionnaires. Furthermore, we assess participants experiences of study participation qualitatively by means of semi-structured interviews.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartAug 2, 2018
Primary CompletionJun 28, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.1 years ago

Interventions

P-Dragees rosa Lichtensteinother

Placebo dragées