NCT05846698

Brief Summary

To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

3.5 years

First QC Date

April 11, 2023

Last Update Submit

August 22, 2023

Conditions

Climacteric Syndrome

Outcome Measures

Primary Outcomes (1)

  • Sex hormone

    3 month

Study Arms (2)

control group

Drug: tibolone

treatment group

Drug: Luo-Bu-Fu-Ke-Bi-RI Pill

Interventions

Luo-Bu-Fu-Ke-Bi-RI PillDRUG

10 pills twice daily

treatment group
tiboloneDRUG

2.5 mg once daily

control group

Eligibility Criteria

Age41 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

female

Clinical diagnosis of climacteric syndrome

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Interventions

tibolone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 6, 2023

Study Start

July 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)