Hypogonadism Clinical Trial
Official title:
Administration of Kisspeptin in Patients With Hyperprolactinemia
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). All participants will receive kisspeptin in a pulsatile fashion. Subjects in one group will attend two 12-hour visits with frequent blood draws. Subjects in the second group will wear a pump that administers kisspeptin subcutaneously (SC) over eight days and attend seven short blood sampling visits.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 29, 2023 |
Est. primary completion date | June 28, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion/Exclusion Criteria: - confirmed diagnosis of elevated levels of prolactin measured via blood test, - no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, - no history of a medication reaction requiring emergency medical care, - no illicit drug use or excessive alcohol consumption (>10 drinks/week), - not currently seeking fertility, breastfeeding or pregnant, - no history of bilateral oophorectomy, - willing to complete a dopamine agonist washout and/or oral contraceptive washout, - normal physical exam and laboratory studies within protocol reference range. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average change in number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm) | Average change in LH pulse frequency at baseline and during kisspeptin IV administration | Up to 23 days | |
Primary | Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm) | Change in follicle size in mm by ultrasound over the course of SC kisspeptin administration | Evaluated over eight days | |
Secondary | Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm) | Average change in LH pulse amplitude at baseline and during kisspeptin administration | Up to 23 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
Terminated |
NCT02419105 -
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
|
Phase 3 | |
Withdrawn |
NCT02137265 -
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
|
N/A | |
Completed |
NCT02222558 -
Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
Completed |
NCT02233751 -
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
|
Phase 1 | |
Completed |
NCT01887418 -
Pharmacokinetic Study of Testosterone Enanthate
|
Phase 1/Phase 2 | |
Terminated |
NCT01092858 -
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
|
Phase 4 | |
Completed |
NCT00624624 -
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
|
N/A | |
Completed |
NCT00752869 -
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
|
Phase 4 | |
Completed |
NCT00613288 -
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
|
N/A | |
Completed |
NCT00119483 -
Older Men and Testosterone
|
N/A | |
Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
Completed |
NCT00004438 -
Leuprolide in Treating Adults With Hypogonadotropism
|
N/A | |
Withdrawn |
NCT00398034 -
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
|
Phase 2 | |
Completed |
NCT02937740 -
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natestoâ„¢
|
Phase 4 | |
Completed |
NCT02921386 -
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
|
Phase 2 | |
Completed |
NCT01717768 -
Oral Testosterone for the Treatment of Hypogonadism
|
Phase 2 | |
Terminated |
NCT01460654 -
Testosterone and Alendronate in Hypogonadal Men
|
Phase 2 | |
Completed |
NCT00998933 -
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
|
Phase 1 | |
Completed |
NCT00857454 -
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
|
Phase 3 |