Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

ConditionsHypothalamic Amenorrhea Hypogonadotropic Hypogonadism

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-45

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 women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Ages 18-45 years

Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)

Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)

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

Pregnant

Trial design

Design model

Single group

Treatments tested in this trial

kisspeptin 112-121
Drug
SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Kisspeptin pumpExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change of luteinizing hormone (LH) pulse amplitude

Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

Time frame

2 weeks

Other outcomes

The proportion of participants that achieve development of a mature follicle or show evidence of ovulation

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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