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Healthy women test new Long-Acting hormone drug injection

NCT ID NCT06315205

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This early-stage study tests a single injection of a long-acting form of letrozole in 90 healthy post-menopausal women. The goal is to measure how the drug moves through the body and check for side effects. Participants receive one injection and are monitored closely. No direct health benefit is expected, but results will guide future research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

84 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy post-menopausal women. * Capable of providing informed consent. * Weight of ≥50 kg and a BMI ≥19 and ≤39 kg/m2. * Subjects should be able to communicate with clinic staff. Exclusion Criteria: * Subjects who have a history of allergy or hypersensitivity to letrozole or any of the inactive ingredients. * Subjects who have a history of galactose intolerance, severe hereditary lactase deficiency glucose-galactose malabsorption. * Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH) releasing hormone analogs, prolactin inhibitors, or antiandrogens within prior to Screening. * Subjects who have used: any medications including St. John's wort or any medications or products known to be potent or moderate inhibitors of CYP P450 3A4. * Subjects who have been diagnosed with osteoporosis. * Subjects who have an abnormality at Screening or prior to first dose that in the opinion of the investigator increases the risk of participating in the study. * Subjects who have any clinically significant abnormal physical examination or laboratory safety findings at screening. * Subjects who have relevant diseases or clinically significant abnormal relevant findings at Screening, as determined by medical history, physical examination, laboratory, ECG, DEXA, and breast and pelvic examination. * Subjects who have history of any significant chronic disease. * History of cancer within the past 5 years with the exception of non-melanoma skin cancer. * Subjects who have a history of drug-dependence, and recent history of alcoholism or abuse of alcohol. * Subjects who have received a drug in research or have participated in other clinical trials within 90 days, prior to dosing. * Any other unspecified reason that, in the opinion of the investigator (or designee) or sponsor, makes the subject unsuitable for enrolment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigational Site number CZ-01

    Prague, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.