A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide for pcos.

Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner.

It had two arms (groups): Treatment Group (active comparator) and Control Group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

PERIODS is a prospective, phase IV, multi-centre, randomized, double-blind and placebo-controlled clinical trial that will investigate the effects of tirzepatide compared with placebo on ovarian dysfunction in premeno-pausal, overweight (BMI ≥ 27 kg/m2) women with PCOS.

The safety follow-up period will be 4 weeks (for subjects completing or discontinuing IMP during the first 72 weeks).

Long-term follow-up will be one year after discontinuation of IMP.

The trial design is multi-centred with a planned number of 5 participating trial sites in Germany.

Who Took Part

The registry lists 198 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial. Motivated, capable, and willing to self-inject IMP, as required for this protocol. Motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, includ-ing, but not limited to lifestyle, dietary and exercise advice. Motivated, capable, and willing to complete trial diaries and required questionnaires. Females aged 18 - 45 years of childbearing potential.

The full record lists 12 inclusion and 37 exclusion criteria; among the exclusions: note: subjects with a lifetime suicidal event cannot be considered for inclusion; known or persistent abuse of medication, drugs or alcohol; current (positive pregnancy test, e.g., ß-hcg test in urine / serum) or planned pregnancy during the 72-week treatment period from randomization, or nursing women.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Blinding on both sides kept the pcos participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-12-09 with completion listed for 2028-12.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 21 secondary outcomes, for example Percentage of Participants With Normalization of Menstrual Cycle, Change From Baseline in Serum Anti-Müllerian Hormone (AMH), Change From Baseline in Biochemical Androgen Profile, Change From Baseline in Calculated Free Androgen Index (FAI) and Calculated Free Testosterone, Change From Baseline in Pituitary-Gonadal Hormones (LH, FSH, Estradiol, Progesterone) and Percentage Change in Body Weight from Baseline to Week 72.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 198 people with pcos.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, PCOS research.