NCT05896293 Kisspeptin Administration Subcutaneously to Patients With IHH
| NCT ID | NCT05896293 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stephanie B. Seminara, MD |
| Condition | Hypogonadotropic Hypogonadism |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2028-05 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2023-02-03 with a primary completion date of 2028-05.
⚠ 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
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD
Eligibility Criteria
Inclusion Criteria: * Congenital IHH o Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration Exclusion Criteria: * Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol * Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. * Pregnant or trying to become pregnant * Breast feeding * History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
Contact & Investigator
Stephanie Seminara, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05896293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypogonadotropic Hypogonadism. 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 NCT05896293 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05896293 currently recruiting?
Yes, NCT05896293 is actively recruiting participants. Contact the research team at MGHKisspeptinResearch@partners.org for enrollment information.
Where is the NCT05896293 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05896293 clinical trial?
NCT05896293 is sponsored by Stephanie B. Seminara, MD. The principal investigator is Stephanie Seminara, MD at Massachusetts General Hospital. The trial plans to enroll 36 participants.