Last reviewed · How we verify
NCT04925180: Safe-CAM
A Study to Learn About the Awareness and Knowledge That Doctors Have About the Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Treatments in Europe
trial testing Cyproterone Acetate (Androcur, BAY94-8367) in Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea in 600 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 18 October 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 5 locations across France, Netherlands, Germany, Poland, Spain |
Drugs / interventions tested
- Cyproterone Acetate (Androcur, BAY94-8367) — full drug profile →
Conditions studied
- Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea — all drugs for Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea →
- Hypersexuality in Men — all drugs for Hypersexuality in Men →
- Sexual Deviations in Men — all drugs for Sexual Deviations in Men →
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Bayer — full company profile →
Who can join
Eligibility, any sex, with Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea or Hypersexuality in Men. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Androcur is a type of treatment called cyproterone acetate (CPA). Androcur and other CPA treatments work by blocking a group of male sex hormones called androgens in the body. It can be given to men and women to treat conditions that are caused by higher levels of androgens. CPAs, including androcur, are currently available as treatments for doctors to give to patients who have these types of conditions. But, in a study, researchers found that participants had a certain medical problem when they took CPAs for a long time. This medical problem was a tumor of the brain or spinal cord that is mostly not malignant and is called meningioma. This eventually led health authorities to change the instructions for how doctors should use CPAs to treat patients. This included what health conditions should be treated with CPAs, how long patients should receive them, and what dose of CPA should be given. In this study, the researchers want to learn more about how doctors are using CPAs to treat patients after the update to the instructions. To answer this research question, they will give to the doctors a web-based questionnaire asking about the advisability or necessity of the treatment (also called "indications of approved use"), the measures to be followed to reduce the risk and how much the doctors knew about the risk of meningioma. The researches will then analyze the answers to the questionnaire. The results will be the percentage of physicians with correct answers for each individual knowledge question from the questionnaire. The study will include information collected from a diverse sample of doctors during approximately 3 months. The doctors must have given CPAs as a treatment to at least 1 patient in the last 12 months. There are no required visits or tests in this study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Regulation of HNRNP family by post-translational modifications in cancer.
Li B, Wen M, Gao F, Wang Y, et al · · 2024 · cited 13× · PMID 39366930 · DOI 10.1038/s41420-024-02198-7
Verify or expand the search:
- PubMed search for NCT04925180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cyproterone Acetate (Androcur, BAY94-8367)
Trials testing the same drug.
- NCT07145281 — Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment o · NA · completed
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04925180 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 12 January 2022
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/NCT04925180.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing