UnknownNot Applicable

Hormones in Hypogonadotropic Hypogonadism

Austria50 participantsStarted 2023-04-02

Plain-language summary

Therefore, the main objective of this prospective pilot study is to evaluate a complete hormonal profile in women with hypogonadotropic hypogonadism, including anti-mullerian hormone (AMH) and antral follicle count. Changes in this regard will be evaluated after 2 months of individual treatment.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with HH and secondary amenorrhea. HH is defined as absence of spontaneous menstruation for ≥6 months, no abrupt menstrual bleeding after progesterone therapy, and normal or low serum FSH and LH levels. * The patient gave written informed consent to the study after receiving detailed information and education from medical contributors at the Department of Obstetrics and Gynecology, Medical University of Vienna. * Age between \>18 and \<35 years. Exclusion Criteria: * Latent or manifest hypothyroidism (TSH \>4 micromole/milliliter) or current thyroid hormone replacement therapy. * No existing informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AMH

Timeframe: 2 months

antral follicle count

Timeframe: 2 months

Trial details

NCT IDNCT04927676

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06

Contact for this trial

Johannes Ott, MD, PhD

+436504010485 johannes.ott@meduniwien.ac.at

View on ClinicalTrials.gov More AMH trials