Kisspeptin Administration Subcutaneously to Patients With IHH

ConditionHypogonadotropic Hypogonadism

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorStephanie B. Seminara, MD

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Pregnant or trying to become pregnant

Trial design

Design model

Single group

Treatments tested in this trial

kisspeptin 112-121
Drug
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
leuprolide acetate
Drug
Single SC bolus

Treatment groups

36 Participants

are divided into 1 treatment group

Group A: kisspeptin pumpExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Time frame

2 weeks

Secondary outcomes

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.

Time frame

2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephanie B. Seminara, MD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Source ClinicalTrials.gov

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