What is tirzepatide studying for ovarian dysfunction in PCOS?

Tirzepatide is being studied to see if it can improve ovarian dysfunction, especially menstrual irregularity, in women with PCOS who are overweight or obese. The study compares tirzepatide to a placebo to understand its effects. It is sponsored by the University of Bonn and aims to help women with this condition through medical research.

Who may be eligible for this PCOS clinical trial?

Women aged 18 to 45 years with a diagnosis of PCOS and a body mass index (BMI) of 27 or higher may be eligible. Participants must have irregular menstrual cycles and be willing to avoid hormonal contraceptives during the study. The trial is for females only. Please review eligibility criteria for more details.

Is there any cost to participate in this PCOS clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 4

Age: 18Years - 45Years

FEMALE

ID07326111

Study of Tirzepatide to Improve Ovarian Function in Overweight or Obese Women with PCOS

Led by University of Bonn · Updated on 2026-01-08

198

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome PCOS who are overweight or have obesity. This phase IV, multi-center, randomized, double-blind, placebo-controlled trial aims to show that tirzepatide at the maximum tolerated dose is better than placebo for improving menstrual irregularity related to PCOS. The study is conducted at five sites in Germany and focuses on women aged 18 to 45 years with PCOS defined by specific criteria.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years

FEMALE

Eligibility Criteria

You may qualify if you...

Written informed consent to participate in this clinical trial
Females aged 18 to 45 years of childbearing potential
At least 3 years post-menarche and premenopausal
Body mass index (BMI) of 27 kg/m8 or higher
Previous diagnosis of PCOS defined by Rotterdam criteria
Oligomenorrhea or secondary amenorrhea with irregular periods within the last 10 years if on hormonal contraceptives, or within the last year if not
Biochemical signs of hyperandrogenism with total testosterone in upper 95th percentile and free androgen index above normal, or clinical signs of hyperandrogenism
Hormonal contraceptive naive or off hormonal contraceptives for six months prior to screening and willing to use barrier contraception during treatment
Motivated and able to self-inject investigational medicinal product and follow trial procedures including lifestyle changes
Willing and able to complete trial diaries and questionnaires

You will not qualify if you...

Unable to understand the nature and consequences of this clinical trial
Physical or psychiatric conditions that may pose risk or interfere with participation
Lifetime history of suicidal events
Participation in another clinical trial within 30 days prior to screening
Known or persistent abuse of medication, drugs, or alcohol
History of active or untreated malignancy within the last 5 years (excluding certain skin cancers and cervical carcinoma in situ)
Severe renal impairment (eGFR < 30 mL/min/1.73 m8)
Acute or chronic hepatitis or other liver diseases excluding non-alcoholic fatty liver disease
History of gastric emptying abnormalities
Current or planned pregnancy or nursing
Diabetes mellitus other than type 2, or type 2 diabetes with certain treatments or complications
Prior treatment with GLP-1 receptor agonists or dual incretin agonists within 6 months
Use of inositol formulations within 6 months
Congenital adrenal hyperplasia or untreated thyroid, pituitary, or adrenal disease
Hyperprolactinemia
History of benign intrauterine lesions or hysterectomy
Allergies to tirzepatide or related medications
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Elevated calcitonin levels above specified thresholds
Secondary causes of obesity or syndromic forms
History of pancreatitis
Previous or planned bariatric or device-based obesity treatments
Vaginal bleeding of unknown cause
History of thromboembolic events or active thrombophlebitis

Research Team

Wiebke Fenske K. Head of Department at BG Universitätsklinikum Bochum, Professor

Charlotte Fries M. Senior Physician, MD

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