| CTRI Number |
CTRI/2025/10/096596 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to evaluate the effect of oral bicalutamide in improving hair growth in women with female pattern hair loss |
|
Scientific Title of Study
|
Evaluation of a non-steroidal peripherally selective androgen receptor antagonist: oral bicalutamide in female pattern hair loss |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaik Sana Sultana |
| Designation |
Post graduate resident |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences |
| Address |
Room number 118 Department of DVL Asram medical college Eluru malkapuram Andhra
Pradesh
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9618047392 |
| Fax |
|
| Email |
Shaiksana33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirupama Bhagya Lakshmi Tatavarthi |
| Designation |
Professor and HOD MD DVL |
| Affiliation |
Department of DVL ASRAM Hospital |
| Address |
Room number 118 first floor Department of DVL Asram Hospital Eluru malkapuram
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9553164588 |
| Fax |
|
| Email |
niruluckee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaik Sana Sultana |
| Designation |
Post graduate resident |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences |
| Address |
Room number 118 first floor Department of DVL Asram Hospital Eluru malkapuram
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9618047392 |
| Fax |
|
| Email |
Shaiksana33@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shaik Sana Sultana |
| Address |
104 Krishna block new girls
PG hostel behind library Asram medical college Eluru malkapuram Andhra
Pradesh 534005 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaik Sana Sultana |
ASRAM Hospital affiliated to Alluri Sitarama Raju Academy of Medical Sciences |
Room number 118 Department of DVL
Malkapuram Eluru
West Godavari
ANDHRA PRADESH |
9618047392
Shaiksana33@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASRAMS BHR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral bicalutamide |
Patients will be advised to take bicalutamide 25 mg once daily for 5 months.
|
| Comparator Agent |
Oral bicalutamide along with topical minoxidil |
Patients will be advised to take bicalutamide 25 mg once daily along with 1 ml 2% minoxidil once daily for 5 months. |
| Comparator Agent |
Topical 2% minoxidil |
Patients will be advised to use 1 ml 2% minoxidil once daily for 5 months.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female patients diagnosed with FPHL.
Willingness to comply treatment and follow- up schedule.
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Prior use of antiandrogens or hormone therapies in the last 6 months.
Patients with other types of alopecia, both cicatricial and non cicatricial.
Patients with uncontrolled diabetes, uncontrolled hypertension, and other medical disorders (cardiac, renal, hepatic, immunocompromised, epilepsy).
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hair density number of terminal hairs per cm square from baseline to the end of the treatment period measured by standardized global scalp photography and dermoscopy |
8 weeks 12 weeks and 20 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare changes in Sinclair and Ludwig grading scores across the three groups |
8 weeks 12 weeks and 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
14/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study titled Evaluation of a Non Steroidal Peripherally Selective Androgen Receptor Antagonist Oral Bicalutamide in Female Pattern Hair Loss aims to assess the efficacy of oral bicalutamide alone and in combination with topical minoxidil in improving hair growth among female patients aged 20 to 50 years diagnosed with FPHL Existing treatments such as minoxidil and oral antiandrogens have variable outcomes and notable side effects highlighting the need for safer more effective alternatives The study will be conducted over 18 months and will include 84 participants divided into three groups bicalutamide alone minoxidil alone and combination therapy Baseline and follow-up assessments will be done at 8 12 and 20 weeks including clinical photography trichoscopy hair density measurement and patient satisfaction scoring using standardized scales Sinclair Ludwig and Patient Global Assessment By comparing changes in hair density grading scores and patient reported outcomes the study seeks to establish the therapeutic potential and safety of oral bicalutamide as a novel treatment option for female pattern hair loss
|