Reproductive Hormones During Sustained Administration of Kisspeptin

What Was Tested

The trial (not phased) is built around Kisspeptin-10.

It had four arms (groups): Kisspeptin 0.1 (active comparator), Saline (placebo comparator), Kisspeptin 0.3 (active comparator) and Kisspeptin 1.0 (active comparator).

Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.

The registry classes the interventions as other.

More on the Plan

Participants will be invited to have an initial baseline study to look at the hormone levels at regular intervals over the course of a day (8hours).

Following this, on a different day, volunteers will have an infusion of kisspeptin, which will be administered by a small pump to deliver the hormone into subcutaneous tissue (fatty tissue just below the skin surface).

On day 1 of the pump infusion there will be another day of regular blood sampling for 8 hours.

After this the kisspeptin pump will continue and the participants will return to the research unit on day 3 for a review and a single blood test.

Who Took Part

Enrollment: 76 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 18-60 years old. Ability to give informed consent. Secondary hypogonadism (or healthy participant).

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: medical problems such as severe heart, kidney or liver disease; blood donation in the last three months or intention to donate blood within 3 months of the end of the study; needle phobia.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

The participants were allocated by chance, so the Kisspeptin-10 group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Kisspeptin-10 and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Kisspeptin-10 was given.

Those kept unaware of assignments: participant.

It started in 2014-04-02 with completion listed for 2027-11-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of Kisspeptin on hypothalamic reproductive function - LH levels (time frame: 3 months).

It also tracked 3 secondary outcomes, for example Effect of Kisspeptin on hypothalamic reproductive function - FSH levels and Effect of Kisspeptin on hypothalamic reproductive function - Oestradiol levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Kisspeptin-10 in 76 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Kisspeptin-10 compound page, all human trials.