NCT07124221 A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
| NCT ID | NCT07124221 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Hyperprolactinemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 382 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2026-11-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 382 participants in total. It began in 2025-09-12 with a primary completion date of 2026-11-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
Eligibility Criteria
Inclusion Criteria: * Women aged 18 to 45 at the time of signing the ICF; * Clinically diagnosed hyperprolactinemia, with or without pituitary PRL tumor; * Agree to and abide by the adoption of effective contraceptive measures during the study period (from signing the ICF to 4 weeks after the last administration of the investigational drug); * voluntarily signed the ICF, could understand and abide by the requirements of this research protocol, and were followed up regularly and on time. Exclusion Criteria: * Women who are pregnant or breastfeeding; * Those who have previously received carbergoline treatment or radiotherapy, or have a history of allergy to ergol preparations or their derivatives; * The presence of other types or mixed pituitary tumors； * hyperprolactinemia syndrome caused by hypothalamic or other intracranial lesions； * hyperprolactinemia syndrome caused by other systemic diseases; * Laboratory tests during the screening period meet any of the following conditions: 1. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 times ULN, or total bilirubin (TBIL) \> 1.5 times ULN, or serum creatinine (Cr) or UREA (UREA)/urea nitrogen (BUN) \> 2 times ULN; 2. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody and Treponema pallidum antibody; 3. Hyperprolactinemia: Screening tests show that the PRL recovery rate is less than 40%; * Those who have received ovulation-inducing agents, drugs that may cause an increase in PRL or other prohibited combination drugs within 4 weeks prior to screening; * The patients not suitable for participating in this clinical study due to other reasons.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124221 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Hyperprolactinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124221 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 382 participants.
Is NCT07124221 currently recruiting?
Yes, NCT07124221 is actively recruiting participants. Contact the research team at lilingling01@genscigroup.com for enrollment information.
Where is the NCT07124221 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07124221 clinical trial?
NCT07124221 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. The trial plans to enroll 382 participants.