Fertility and sexual function in people with congenital adrenal hyperplasia
Official title: Channelling Fertility And Sexual Function In Congenital Adrenal Hyperplasia. CALLIOPE: An Observational, Longitudinal Pilot Study
Run by University of Roma La Sapienza · NCT07099456 · Data updated 2026-11-12
This study will test whether new CAH treatments improve fertility and sexual health in adults with congenital adrenal hyperplasia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | November 1, 2029 |
| Study ends | November 1, 2030 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT07099456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed diagnosis of CAH—men aged 18–65 and pre‑menopausal women aged 18–55—who are medically stable and not taking interfering hormonal therapies are ideal candidates.
✕Probably not a fit
People who are postmenopausal, have BMI >40 kg/m2, require chronic steroids for other conditions, have severe liver or kidney disease, active substance abuse, uncontrolled thyroid or psychiatric disease, or unstable use of hormonal contraceptives are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CALLIOPE is a multicenter observational study enrolling adult men (18–65) and pre‑menopausal women (18–55) with confirmed CAH to collect clinical, biochemical and reproductive data. Investigators will use standardized LC‑MS/MS hormone assays, semen analyses for men, and validated questionnaires and exams to document sexual function and fertility markers. The study compares outcomes across contemporary pharmacologic management strategies to explore associations between treatment patterns and reproductive health. Common exclusion criteria (for example major organ failure, other steroid-requiring conditions, disruptive psychiatric disease, or hormonal-interfering medications) are applied to reduce confounding.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose treatments that improve fertility and sexual health for people with CAH.
How similar studies have gone: Anecdotal reports and small recent trials have suggested improvements in sperm counts and menstrual regularity with novel CAH therapies, but robust prospective evidence on fertility outcomes remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, males in the age range 18-65 years and pre-menopausal females in the age range 18-55 years; * a known/new diagnosis of CAH. Exclusion Criteria: * BMI \> 40 Kg/m2; * Any other concomitant condition requiring steroid treatment; * Severe liver and/or kidney disease; * Thyroid dysfunctions (overt hyperthyroidism and hypothyroidism); * Malignant neoplasms; * Drug and alcohol abuse; * Use of drugs acting on hormonal levels (e.g. antiandrogens); * Psychiatric diseases; * Postmenopausal women; * Women taking combined oral contraceptive pill (women) or other contraceptives will require stability for at least 6 months.
Where it's running
-
Department of Experimental Medicine, Sapienza University of Rome
Rome, Italy, Italy Recruiting
Study contacts
- Study coordinator: Andrea M Isidori, MD, PhD, FRCP
- Email: andrea.isidori@uniroma1.it
- Phone: +39 0649970540
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.