HyperprolactinemiaPhase 3NCT07124221
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
A Phase 3 study testing Cabergoline tablets and Bromocriptine mesylate tablets in people with Hyperprolactinemia, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hyperprolactinemia
- What is being tested?
- Cabergoline tablets and Bromocriptine mesylate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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;
- Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody and Treponema pallidum antibody;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
HuiJuan Zhu, Doctor of Medicine, 010-69155073, shengxin2004@163.com
ChengYan Deng, Doctor of Medicine, 010-69158846, chydmd@hotmail.com
About this study
Official title: A Randomized, Double-blind, Double-dummy, Positive Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets in Female Patients With Hyperprolactinemia
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
Read the detailed description
A randomized, double-blind, double-dummy, active controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Cabergoline tablets compared with Bromocriptine mesylate tablets in female patients with hyperprolactinemia
- Conditions
- Hyperprolactinemia
- Being tested
- Cabergoline tablets, Bromocriptine mesylate tablets
- Medical subject headings
- Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline tabletsDrug
Cabergoline tablets will be administered for 14 weeks.The allowed dose range is from 0.25 mg (1 tablet) QW to 1mg (4 tablets) QW. Dosage adjustments are made based on the serum PRL level.
Bromocriptine mesylate tabletsDrug
Bromocriptine mesylate tablets was administered for 14 weeks.The dose is 1.25 mg (0.5 tablet) QD to 7.5mg 3 tablets) QD. Dosage adjustments are made based on the serum PRL level.
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline tablets | Experimental | 191subjects Receives: Drug: Cabergoline tablets |
| Bromocriptine mesylate tablets | Active comparator | 191subjects Receives: Drug: Bromocriptine mesylate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects whose serum PRL levels returned to normal
Measured: 14 weeks
Secondary outcomes (3)
The percentage of subjects whose ovulatory cycles resumed
Measured: 14 weeks
The percentage of subjects whose galactorrhea disappeared
Measured: 14 weeks
The percentage of subjects with pituitary PRL tumor shrinkage
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start12 Sep 2025
- Primary completion21 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cabergoline tablets compared with Bromocriptine mesylate tablets
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124221
- Sponsor's protocol ID
- GenSci127-301
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Positive Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets in Female Patients With Hyperprolactinemia
- ClinicalTrials.gov ID
- NCT07124221
- Acronym / sponsor ID
- GenSci127-301
- Conditions
- Hyperprolactinemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
Detailed description
A randomized, double-blind, double-dummy, active controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Cabergoline tablets compared with Bromocriptine mesylate tablets in female patients with hyperprolactinemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cabergoline tablets compared with Bromocriptine mesylate tablets
| Arm | Type | Receives |
|---|---|---|
| Cabergoline tablets | Experimental | Drug: Cabergoline tablets191subjects |
| Bromocriptine mesylate tablets | Active comparator | Drug: Bromocriptine mesylate tablets191subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline tabletsCabergoline tablets will be administered for 14 weeks.The allowed dose range is from 0.25 mg (1 tablet) QW to 1mg (4 tablets) QW. Dosage adjustments are made based on the serum PRL level. | Drug | Cabergoline tablets |
| Bromocriptine mesylate tabletsBromocriptine mesylate tablets was administered for 14 weeks.The dose is 1.25 mg (0.5 tablet) QD to 7.5mg 3 tablets) QD. Dosage adjustments are made based on the serum PRL level. | Drug | Bromocriptine mesylate tablets |
Primary outcome
The percentage of subjects whose serum PRL levels returned to normal
Time frame: 14 weeks
3 secondary outcomes
The percentage of subjects whose ovulatory cycles resumed
Time frame: 14 weeks
The percentage of subjects whose galactorrhea disappeared
Time frame: 14 weeks
The percentage of subjects with pituitary PRL tumor shrinkage
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cabergoline tablets and Bromocriptine mesylate tablets in people with Hyperprolactinemia, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lingling Li (+86-18826108784, lilingling01@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects whose serum PRL levels returned to normal (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.