Pharmacokinetic properties of vaginal progesterone gel in Chinese healthy postmenopausal women

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16009879

Enrollment

Unknown

Registered

2016-11-16

Start date

2010-10-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fertility and sterility

Interventions

Test 4%:To evaluate the safety and pharmacokinetics of 45 mg vaginal progesterone gel (Test 4%) following single dose and multiple doses administered every other day (q.o.d.) for 6 times or once daily

Test 8%:To evaluate the safety and pharmacokinetics of 45 mg vaginal progesterone gel (Test 8%) following single dose and multiple doses administered every other day (q.o.d.) for 6 times or once daily

Crinone 8%:To evaluate the safety and pharmacokinetics of 45 mg vaginal progesterone gel (Crinone 8%) following single dose and multiple doses administered every other day (q.o.d.) for 6 times or once

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) healthy postmenopausal women; (2) Subject is 40~65 years old and the age difference should less than 10 years in the same batch; (3) BMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)]; (4) Medical history, physical examination and clinical examination is normal; (5) Without disease history of major organs nor without drug or any other allergies; (6) Non drug/alcohol abusers; (7) Withourt using any medicine in the last 2 weeks; (8) Subject is able to communicate with investigator well and comply with requires of study; (9) Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Participate other clinical trials in the last 3 months; (2) Blood donation in the last 1 month or intend to donate blood in the following 1 month; (3) The general examination and blood pressure, heart rate and respiratory conditions, such as those who are not qualified; (4) Physical examination results judged as clinical significance of abnormal; (5) Laboratory tests found abnormalities in blood, heart, liver and kidney dysfunction; (6) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

Measure	Time frame
AUC0-t;Cmax;Tmax;t1/2;AUCss;Cmax,ss;DF;	—

Countries

China

Contacts

Public ContactShentu Jianzhong

The First Affiliated Hospital, School of Medicine, Zhejiang University

stjz@zju.edu.cn+86 13957111817

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026