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New treatment option for Hypothalamic Amenorrhea
Official title Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
ClinicalTrials.gov ID: NCT07224438
What this study is testing
What is kisspeptin 112-121?
kisspeptin 112-121 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypothalamic amenorrhea.
Also referred to as Metastin 45-54.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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)
- Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
You likely 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...
- Excessive alcohol consumption (\>10 drinks/week)
- Active use of illicit drugs
- Pregnant
- Trying to become pregnant during protocol participation
- Breast feeding
See the full eligibility criteria
- 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)
- Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
- Negative serum hCG pregnancy test
- No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis OR willing to complete an appropriate washout for that...
- 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
- 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
- Trying to become pregnant during protocol participation
- Breast feeding
- History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.