CompletedNot Applicable

A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel

China48 participantsStarted 2024-06-25

Plain-language summary

The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs. The primary question it seeks to answer is: Does body composition affect the absorption, distribution, and metabolism of drugs? Healthy adult postmenopausal female subjects participating in the quality and efficacy consistency evaluation project for the generic progesterone vaginal sustained-release gel conducted at our hospital will undergo body composition analysis. By combining pharmacokinetic parameters and adverse drug reactions, the study will analyze differences in the metabolism of progesterone vaginal sustained-release gel under various body composition conditions. During the Phase I clinical trial, under the guidance of the researchers, subjects will use the non-invasive InBody S10 body composition analyzer to obtain body composition data, including but not limited to inorganic salts, muscle mass, lean body mass, body weight, and body fat percentage.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who have been successfully enrolled in the bioequivalence trials of Progesterone Sustained-release vaginal gel；
. Have signed the informed consent form, have a full understanding of the content, process, and risks of this study, and can communicate well with the researchers.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fat percentage (%)

Timeframe: The day before using drug，and 1 to 4 days after using drug

Weight

Timeframe: The day before using drug，and 1 to 4 days after using drug

Waist circumference

Timeframe: The day before using drug，and 1 to 4 days after using drug

Trial details

NCT IDNCT07097246

SponsorSecond Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-29

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who have been successfully enrolled in the bioequivalence trials of Progesterone Sustained-release vaginal gel；
. Have signed the informed consent form, have a full understanding of the content, process, and risks of this study, and can communicate well with the researchers.