What this study is
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
What's being tested
- kisspeptin 112-121
Intervention · DRUG
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
- leuprolide acetate
Intervention · DRUG
Single SC bolus
Study details
- Official title
- Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
- Sponsor
- Stephanie B. Seminara, MD
- Conditions
- Hypogonadotropic Hypogonadism
- Enrolling
- 36 people
- Starts
- 2023-02-03
- Est. completion
- 2028-05
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Study Coordinator · Contact617-726-1895MGHKisspeptinResearch@partners.org
Recruiting
Study team
Sponsor
Stephanie B. Seminara, MD
Study ID FD007843
Principal investigator
Stephanie Seminara, MD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.