Healthy women test new Long-Acting hormone drug injection
NCT ID NCT06315205
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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84 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Mar 2026
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Investigational Site number CZ-01
Prague, Czechia
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Other studies related to the condition(s) this trial covers.
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