How body composition may affect drug absorption and metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect body composition data using the InBody S10 and link these measurements to pharmacokinetic parameters and adverse drug reactions observed in bioequivalence trials of a progesterone vaginal gel. The study analyzes how factors like muscle mass, fat, and lean body mass relate to drug handling in the body. It is an observational design, focusing on existing trial participants to explore potential associations. No intervention beyond data collection is planned.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants who have been successfully enrolled in the bioequivalence trials of Progesterone Sustained-release vaginal gel；
2. 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:

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.

Where it's running

• The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Li
• Email: liting1021@aliyun.com
• Phone: 0577-88002664

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.