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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, 325802, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

1）Participants who may not be able to complete the study for other reasons or are deemed by the investigator to be unsuitable for participation in this study.

Treatment and study plan

Primary outcomes

Fat percentage (%)

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

Using a body composition analyzer：Inbody S10, non-invasively obtain the subject's body composition data。This instrument applies a very small electrical current to the body and obtains data on various body components based on the characteristics of different body compositions, including fat percentage (%)
Weight

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

Weight (kilogram) measured using a body weight scale.
Waist circumference

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

Using a body composition analyzer：Inbody S10, non-invasively obtain the subject's body composition data。This instrument applies a very small electrical current to the body and obtains data on various body components based on the characteristics of different body compositions, including Waist circumference（centimeter）

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 31, 2025
Registry last updated: Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed