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CTRI Number  CTRI/2010/091/000593 [Registered on: 18/06/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Diane 35 plus Finasteride combination with Diane 35 plus Spironolactone in the treatment of hirsutism with six months follow-up after stopping the drug. 
Scientific Title of Study   Comparison of Diane 35 plus Finasteride combination with Diane 35 plus Spironolactone in the treatment of hirsutism with six months follow-up after stopping the drug. 
Secondary IDs if Any  
Secondary ID  Identifier 
2007- 00940  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Alka Kriplani 
Designation   
Affiliation   
Address  Dept of Obst & Gynecology
AIIMS
New Delhi
DELHI
110029
India 
Phone  26594933  
Fax    
Email  kriplanialka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Alka Kriplani 
Designation   
Affiliation   
Address  Dept of Obst & Gynecology
AIIMS
New Delhi
DELHI
110029
India 
Phone  26594933  
Fax    
Email  kriplanialka@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Garima Kachhawa 
Designation   
Affiliation   
Address  Dept of Obst & Gynecology
AIIMS
New Delhi
DELHI
110029
India 
Phone  9968382309  
Fax    
Email  garimakhadgawat@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi  
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Alka Kriplani  AIIMS, New Delhi  Dept of Obst & Gynecology,AIIMS-110029
New Delhi
DELHI 
26594933

kriplanialka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hirsutism, acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diane 35 plus Finasteride  Diane 35 from Day 5 to Day 25 of MC and Finasteride 5 mg per day for 12 months 
Comparator Agent  Diane 35 plus Spironolactone  Diane 35 from Day 5 to Day 25 of MC and Spironolactone100 mg per day for 12 months 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  -Women with hirsutism score more than 8 - Age between 18 -40years 
 
ExclusionCriteria 
Details  - postmenoopausal women - pregnant women - CAH - already on some medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Hisutism score  3,6,9, 12 and 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in acne score  3,6,9,12 and 18 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="" 
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   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/02/2007 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary   A prospective randomized clinical trial was conducted on 120 Indian women with hirsutism. Group I patients were treated with Diane 35 plus Spironolactone 100 mg daily and group II patients with Diane 35 plus Finasteride 5 mg daily for 12 months. Hirsutism and acne score were graded every 3 months till 18 months. The basal gonadotropins levels and androgens level were measured before the study. Statistical analysis was done by Student?s t-test and repeated measure analysis followed by post hoc comparison. Results: Reduction in hirsutism and acne score at every 3 months interval was significant (p<0.001) and similar between two groups. This shows that if we prolong treatment for more than 12 months, reduction in score will be better. A significant decrease in the hirsutism score of 55.3%±17.2 and 59.4%±17.5 was observed after 12 month in group I and group II respectively. Total reduction in hirsutism & acne score in both the group was similar (P>0.05). Conclusion: Diane 35 plus spironolactone and Diane 35 plus finasteride are equally effective and safe in the treatment of hirsutism and acne. Treatment period should be more than 12 months for better outcome.  
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