CTRI

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CTRI Number

CTRI/2025/09/094722 [Registered on: 12/09/2025] Trial Registered Prospectively

Last Modified On:

12/09/2025

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Single Arm Study

Public Title of Study

This study aims to measure the concentration of Mifepristone in the uterine tissue and plasma.

Scientific Title of Study

A pharmacokinetics study to determine the blood and uterine tissue concentrations of mifepristone

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Smriti Gupta
Designation	HOD
Affiliation	Subharti Medical College
Address	Obs and Gynae Department Subharti Medical College Meerut UP Meerut UTTAR PRADESH 250005 India
Phone	9837027249
Fax
Email	sharaddodiya@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Sharad Singh
Designation	Consultant
Affiliation	Womed
Address	Basement A 144 Sector 48 Noida GB Nagar Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone	9873722214
Fax
Email	drsinghsharad@gmail.com

Details of Contact Person
Public Query

Name	Dr Sharad Singh
Designation	Consultant
Affiliation	Womed
Address	Basement A 144 Sector 48 Noida GB Nagar UTTAR PRADESH 201301 India
Phone	9873722214
Fax
Email	drsinghsharad@gmail.com

Source of Monetary or Material Support

Womed 1919 route de Mende 34090 Montpellier, France

Primary Sponsor

Name	Womed
Address	1919 route de Mende 34090 Montpellier, France
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Smriti Gupta	Subharti Medical College Hospital	Room no. 5 , 5th Floor, HOD Department of Obs & Gynae Subharti Medical College Hospital Meerut UTTAR PRADESH	9837027249 sharaddodiya@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Swami Vivekanand Subharti University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Women with fibroids will take Mifepristone for 20 days before hysterectomy to measure its levels in uterine tissue and plasma.

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not applicable	Not applicable
Intervention	Tablet Mifepristone	Participants will receive Mifepristone tablets 10/25 mg for 20 days and then uterus and blood samples will be collected from subjects undergoing hysterectomy, then they will be transferred to the bioanalytical lab for analysis of mifepristone concentration.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Female
Details	1. Planned hysterectomy for one or more symptomatic fibroids 2. Age 18 to 50 years 3. Is willing to participate in study and consented for the same 4. Is willing to take daily oral treatment of 10 mg or 25 mg mifepristone during 20 days before hysterectomy 5. Is willing to give blood sample before starting Mifepristone and after completing 20 doses

ExclusionCriteria

Details

Medical History
1. Post menopausal
2. Any contraindication to hysterectomy
3. Uterus larger than a sixteen weeks gestation uterus as measured by pelvic manual examination
4. Abnormal liver and renal function
5. History of relevant known or suspected malignant tumors.
6. History of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
7. Contraindication to mifepristone, including: adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
8. History of allergy to Mifepristone
Prior or concomitant medication
9. CYP3A inhibitors (itraconazole, voriconazole, clarithromycin, erythromycin) or inducers (barbiturates, carbamazepine, nevirapine, phenytoin, primidone, rifabutin, rifampicin, ritonavir, herbals containing hypericum perforatum) as well as consumption of grapefruit and derivatives (juices etc…).
10. Participation in clinical studies of drugs in the past 3 months
Other
11. Inability to establish a venous catheter for blood sampling.
12. Regular consumption of more than 10 g of alcohol per day or anamnestic information about alcoholism, drug addiction, drug abuse.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The primary research objective of the current study is to obtain uterine tissue concentrations after 20 days of daily oral treatment with mifepristone at 10 and 25 mg/day.	Mifepristone tissue concentrations at trough levels after 20 days of daily treatment in endometrium, myometrium and fibroid tissue

Secondary Outcome

Outcome	TimePoints
A secondary objective is to obtain the corresponding systemic concentrations	Plasma concentrations of mifepristone at trough levels after 20 days of daily treatment

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

30/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is an exploratory pharmacokinetics study to evaluate the blood and uterine tissue concentrations of mifepristone in women with symptomatic uterine fibroids scheduled for hysterectomy. Mifepristone is a selective progesterone receptor modulator already approved in India for fibroid treatment at oral doses of 5 mg, 10 mg and 25 mg. Local uterine concentrations after oral dosing are not known and this study aims to generate this data to guide future therapeutic approaches including local administration routes.

The primary objective is to measure uterine tissue levels of mifepristone in endometrium myometrium and fibroid tissue after 20 days of daily oral treatment with 10 mg or 25 mg. The secondary objective is to assess systemic plasma concentrations at the same time point.

The design is a single arm open label exploratory tissue distribution study. A total 20 women aged 18 to 50 years scheduled for hysterectomy due to symptomatic fibroids will be enrolled at a single site in India. Patients 1 to 10 will receive 25 mg daily while patients 11 to 20 will receive 10 mg daily for 20 consecutive days before hysterectomy.

Blood samples will be taken before the first dose and 24 hours after the final dose. Uterine tissues including endometrium myometrium and fibroid tissue will be collected during hysterectomy 24 hours after the last dose. All samples will be analyzed using LC MS to determine concentrations.

Inclusion criteria are women aged 18 to 50 years planned for hysterectomy for symptomatic fibroids who are willing to take the study medication and provide samples. Key exclusions include postmenopausal status contraindications to mifepristone abnormal liver or renal function malignant disease unexplained bleeding use of CYP3A modulators or significant alcohol or drug abuse.

The study duration per subject is 20 days of treatment plus the hysterectomy procedure.

The trial will follow Good Clinical Practice and ISO 14155 2020 guidelines. Risks are minimal as hysterectomy and mifepristone treatment are part of routine care. Additional risk is limited to blood sampling.