Kisspeptin for Hypothalamic Amenorrhea

Overseen By Study Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Stephanie B. Seminara, MD

Must not be taking: Hormonal replacement

Disqualifiers: Excessive alcohol, Illicit drugs, Pregnant, Breast feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether kisspeptin, a natural hormone, can help women with hypothalamic amenorrhea (a condition where stress or weight loss stops menstruation) release reproductive hormones and eggs. Participants will receive kisspeptin through a small pump for two weeks, while doctors monitor hormone levels and egg growth. This trial suits women who have stopped menstruating due to this condition and are not on certain medications that affect hormones. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking your current medications if they can affect reproductive hormones, but it depends on the specific medication. The study may require a washout period (time without taking certain medications) before you can participate.

Is there any evidence suggesting that kisspeptin is likely to be safe for humans?

Studies have shown that kisspeptin can safely increase the release of reproductive hormones in women. Earlier research administered kisspeptin through an infusion, boosting hormone activity without major safety issues. No significant side effects were reported, indicating good tolerance.

The current study uses a similar method, delivering kisspeptin just under the skin in an on-and-off pattern. While kisspeptin remains under investigation, past safety results are encouraging and suggest it might be a safe option for women with hypothalamic amenorrhea. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hypothalamic amenorrhea?

Kisspeptin is unique because it directly targets the root cause of hypothalamic amenorrhea by stimulating the release of reproductive hormones from the brain. Unlike traditional treatments that often involve hormone replacement therapy to address the symptoms, kisspeptin works naturally with the body's hormone signaling system. Researchers are excited about this treatment because it offers a more physiological approach that may restore natural menstrual cycles without the need for synthetic hormones. Additionally, its administration via a pulsatile pump mimics the body's natural hormone release patterns, potentially leading to better outcomes and fewer side effects.

What evidence suggests that kisspeptin might be an effective treatment for hypothalamic amenorrhea?

Studies have shown that kisspeptin plays a crucial role in releasing hormones necessary for reproduction. This hormone triggers the release of GnRH, which regulates the menstrual cycle, and increases the activity of LH, another hormone involved in reproduction, in women with hypothalamic amenorrhea (HA). Research indicates that kisspeptin can raise LH levels, potentially restoring normal reproductive function. Some studies used kisspeptin infusions and found that it temporarily increased LH release in women with HA. These findings suggest that kisspeptin might help women with HA release eggs from their ovaries. Participants in this trial will receive kisspeptin via a pump for two weeks to evaluate its effects on reproductive function. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for women with hypothalamic amenorrhea, a condition where menstruation stops due to a problem in the brain. Participants should have this specific type of amenorrhea and be willing to undergo frequent blood sampling and ultrasound monitoring.

Inclusion Criteria

Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women

Negative serum hCG pregnancy test

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive subcutaneous administration of kisspeptin in a pulsatile fashion for two weeks

2 weeks

4 visits (in-person) for blood sampling and ultrasounds

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Kisspeptin

Trial Overview The study tests if kisspeptin, a hormone, can trigger reproductive hormones and egg release in affected women. It involves getting kisspeptin shots under the skin over two weeks while tracking hormone levels and ovarian changes.

How Is the Trial Designed?

Group I: Kisspeptin pump Experimental Treatment 1 Intervention

SC administration of kisspeptin for two weeks (pulsatile)

Who Is Running the Clinical Trial?

Stephanie B. Seminara, MD

Lead Sponsor

Trials

10

Recruited

840+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15220

Kisspeptin in functional hypothalamic amenorrhea ... These data evidence the role of endogenous hypothalamic kisspeptin in positively regulating GnRH and downstream LH pulsatile release. Indeed, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7418467/

Current understanding of hypothalamic amenorrhoea - PMC The most promising role for kisspeptin as a therapeutic option in FHA comes from the use of a continuous infusion of kisspeptin at variable doses over 10 hours, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1471489222001151

Stress, kisspeptin, and functional hypothalamic amenorrhea In this study, the authors found that amenorrheic adolescents tended to have a lower serum kisspeptin concentration, although this finding was not statistically ...

4. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(23)00282-3/fulltext

Functional Hypothalamic Amenorrhea: Recognition and ... Another study has found that intravenous infusion of high-dose kisspeptin protein can temporarily increase the LH pulsatility in women with FHA and thus can ...

5. academic.oup.com academic.oup.com/jcem/article/102/5/1413/3077281

Functional Hypothalamic Amenorrhea: An Endocrine Society ... Researchers have investigated kisspeptin as a possible modality for restoring LH pulsatility and gonadal function in women with FHA. Jayasena et al. (240) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07224438

Study Details | NCT07224438 | Kisspeptin Administration ... 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 ...