Current partner codePEPTIDESDE
NCT05896293·Phase 2·INTERVENTIONAL

Kisspeptin Administration Subcutaneously to Patients With IHH

Status

Recruiting

Phase

Phase 2

Enrollment

36

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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

Interventions

Treatment arms and agents.

DRUG

kisspeptin 112-121

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

DRUG

leuprolide acetate

Single SC bolus

Timeline

From registration to results.

  1. First posted

    Jun 9, 2023

  2. Study start

    Feb 3, 2023

  3. Primary completion

    May 2028

  4. Study completion

    May 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 13, 2026

Outcomes

What the study measures.

Primary outcomes

Average change in luteinizing hormone (LH) pulse amplitude

Time frame · 2 weeks

Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)

Secondary outcomes

Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation

Time frame · 2 weeks

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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 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) * 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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Leuprolide.

Related PeptideStat pages

Put the record in context.

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