A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
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ClinicalTrials.gov Identifier: NCT03309319 |
Recruitment Status : Unknown
Verified October 2017 by Zhaoyun Zhang, Huashan Hospital.
Recruitment status was: Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pituitary Tumor | Drug: Rosiglitazone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas |
Actual Study Start Date : | October 16, 2016 |
Estimated Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Ros
Rosiglitazone:2 times a day, 4mg each time(4mgBid)
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Drug: Rosiglitazone
rosiglitazone is added to the primary treatment |
- Growth hormone(GH) [ Time Frame: 6 months ]the decrease of growth hormone(GH)
- insulin like factor 1(IGF-1) [ Time Frame: 6 months ]the decrease of insulin like factor 1(IGF-1)
- tumor volume [ Time Frame: 6 months ]the change of tumor volume

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with GHomas confirmed by surgery
- Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test(OGTT)>1.0ug/L or IGF-1 exceeds age matched normal range
Exclusion Criteria:
- Patients who were allergic to rosiglitazone
- Patients with liver or kidney dysfunction, respiratory failure
- Patients with heart failure
- Patients with edema
- Patients with severe hyperlipidemia
- Patients with osteoporosis or a history of non traumatic fractures
- Patients with pregnancy and lactation
- Patients who had received radiation therapy within 3 years
- Patients who had participated in other clinical trials within 3 months
- Patients with other neoplastic diseases
- Patients with mental and neurological disorders
- Patients with other conditions which were believed not appropriate to take part in the clinical trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309319
China, Shanghai | |
Huashan Hospital | Recruiting |
Shanghai, Shanghai, China, 200040 | |
Contact: Min He, Doctor +862152887027 mhe2004@263.net | |
Principal Investigator: Zhaoyun Zhang, Professor |
Responsible Party: | Zhaoyun Zhang, professor, Huashan Hospital |
ClinicalTrials.gov Identifier: | NCT03309319 |
Other Study ID Numbers: |
KY2016-360 |
First Posted: | October 13, 2017 Key Record Dates |
Last Update Posted: | October 13, 2017 |
Last Verified: | October 2017 |
Adenoma Pituitary Neoplasms Growth Hormone-Secreting Pituitary Adenoma Pituitary Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |