Hypogonadotropic HypogonadismPhase 2NCT05896293
Kisspeptin Administration Subcutaneously to Patients With IHH
A Phase 2 study testing kisspeptin 112-121 and leuprolide acetate in people with Hypogonadotropic Hypogonadism, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- kisspeptin 112-121 and leuprolide acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to May 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congenital IHH
- 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
- If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug
Who cannot join
- 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)
- Active use of illicit drugs (not including marijuana)
- For women:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Study Coordinator, 617-726-1895, MGHKisspeptinResearch@partners.org
About this study
Official title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
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
Read the detailed description
Assignment: All study subjects will undergo the same interventions.
Delivery of Interventions:
- Each subject will undergo a review of their medical history, physical exam, and screening laboratories.
- A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.)
- A pelvic ultrasound will be performed on women to assess baseline follicular size.
- A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
- During the course of kisspeptin administration, subjects will
- Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each)
- For women, undergo pelvic ultrasounds (approximately 4 sessions)
- Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- kisspeptin 112-121, leuprolide acetate
- Keywords
- Hypogonadotropic Hypogonadism, Kisspeptin, Idiopathic Hypogonadotropic Hypogonadism
- Medical subject headings
- Hypogonadism, Idiopathic Hypogonadotropic Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kisspeptin 112-121Drug
Also called metastin 45-54
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
leuprolide acetateDrug
Single SC bolus
| Study group | Role | What they receive |
|---|---|---|
| kisspeptin pump | Experimental | SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study) Receives: Drug: kisspeptin 112-121; Drug: leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in luteinizing hormone (LH) pulse amplitude
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)
Measured: 2 weeks
Secondary outcomes (1)
Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation
Percentage of female participants that develop a mature follicle or ovulate. Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start3 Feb 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Stephanie Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896293
- Sponsor's protocol ID
- FD007843
- Status last verified
- Jul 2026
- First submitted
- 31 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No