NCT05098574 is a Phase 2 clinical trial of Yaz in Premenstrual Dysphoric Disorder, sponsored by St. Joseph's Healthcare Hamilton.

Who is sponsoring NCT05098574?

NCT05098574 is sponsored by St. Joseph's Healthcare Hamilton.

What drugs are being tested in NCT05098574?

Interventions in NCT05098574: Yaz, Placebo.

What condition does NCT05098574 study?

NCT05098574 studies Premenstrual Dysphoric Disorder, Bipolar Disorder.

Is NCT05098574 still recruiting?

NCT05098574 is currently completed. Last updated 23 September 2024.

Last reviewed 2024-09-23 · How we verify

NCT05098574

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

Completed Phase 2 Last updated 23 September 2024

What this trial tests

Phase 2 trial testing Yaz in Premenstrual Dysphoric Disorder in 17 participants. Completed in 11 April 2024.

Timeline

3 February 2023

Primary endpoint
11 April 2024

11 April 2024

Quick facts

Lead sponsor	St. Joseph's Healthcare Hamilton
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	17
Start date	3 February 2023
Primary completion	11 April 2024
Estimated completion	11 April 2024
Sites	1 location across Canada

Drugs / interventions tested

Yaz
Placebo

Conditions studied

Premenstrual Dysphoric Disorder — all drugs for Premenstrual Dysphoric Disorder →
Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

St. Joseph's Healthcare Hamilton — full company profile →

Who can join

Adults 16 to 45, female only, with Premenstrual Dysphoric Disorder or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. Lay Summary: This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians. One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Premenstrual Dysphoric Disorder

Currently open trials in the same condition.

NCT06462391 — Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms · NA · active not recruiting

Other St. Joseph's Healthcare Hamilton trials

Trials by the same sponsor.

NCT06638125 — 3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary · Phase 1, PHASE2 · not yet recruiting
NCT07495228 — Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder · NA · not yet recruiting
NCT07387965 — A Brief Cannabis Use Psychoeducation Intervention for Eating Disorder Patients · NA · not yet recruiting
NCT07349316 — The Effects of Weight and Nutrition Education on Weight Control Beliefs, Body Image, Self-Esteem and Eating Patterns in · NA · not yet recruiting
NCT07250893 — Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05098574 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton
Last refreshed: 23 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05098574.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing