MedTrace Logo

Open-Label Placebo Treatment of Women With Premenstrual Syndrome

NCT03547661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Premenstrual Syndrome

Interventions

OTHER

P-Dragees rosa Lichtenstein

Placebo dragées

Sponsors & Collaborators

  • Jens Gaab

    lead OTHER

Principal Investigators

  • Jens Gaab, Prof. Dr. · University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2021-06-28
Completion
2021-06-28

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547661 on ClinicalTrials.gov