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CTRI Number  CTRI/2022/08/045004 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On: 04/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of combined oral contraceptives and vitamin E against polycystic ovarian syndrome. 
Scientific Title of Study   Clinical evaluation of Drospirenone with ethinyl estradiol and vitamin E add on therapy against polycystic ovarian syndrome- an open label pilot randomized controlled study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Rukaiah Fatma Begum 
Designation  PhD Research scholar 
Affiliation  SRM Institute of Science and Technology 
Address  SRM Institute of Science and Technology, kattankulathur, Chengalpattu, Kancheepuram Tamil Nadu India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9970910201  
Fax    
Email  rukaiah786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Anuradha 
Designation  Professor and Head, Department of Obstetrics and Gynecology 
Affiliation  Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu, kancheepuram, Tamil Nadu India

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  anuthanigai77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Sumithra 
Designation  Associate professor, Department of Pharmacology 
Affiliation  Department of Pharmacology, SRM College of Pharmacy, SRMIST 
Address  SRM College of Pharmacy, Kattankulathur, Chengalpattu, Kancheepuram Tamil Nadu India

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  sumithrm@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM College of Pharmacy SRM Institute of Science and Technology SRM Nagar Kattankulathur Chengalpattu Kancheepuram district Tamil Nadu 603203  
 
Primary Sponsor  
Name  SRM institute of Science and Technology 
Address  SRM Institute of Science and Technology, kattankulathur, Chengalpattu, Tamil Nadu 
Type of Sponsor  Research institution and hospital 
 
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 
Rukaiah Fatma Begum  SRM Medical College Hospital and Research Centre  Room no 45 and 46, Ground floor, Department of Obstetrics and gynecology, Kattankulathur, Chengalpattu, Kancheepuram Tamil Nadu. 603230 India
Kancheepuram
TAMIL NADU 
9970910201

rukaiah786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Drospirenone with ethinyl estradiol  3mg drospirenone with 20mcg ethinyl estradiol OD for 3 months. 
Intervention  Vitamin E  200 mg OD for group 2 and 400 mg OD for group 3 for 3 months 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Diagnosed with polycystic ovarian syndrome according to Rotterdam criteria and did not use any injectable or implant or hormonal contraceptives within 6 months or oral contraception and IUD within 3 months before the study will be included.  
 
ExclusionCriteria 
Details  Women who were pregnant, want to get pregnant or suspected of being pregnant, breastfeeding women, contraindicated for using COCs, diagnosed with concomitant hyperthyroidism, Hyperprolactinemia, diabetes mellitus, renal, or adrenal insufficiency will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Drospirenone and ethinyl estradiol with vitamin E supplements may be better than drospirenone and ethinyl estradiol in relation with oxidative stress as well as hormone balance. Adolescents administered with vitamin E can have regular cycles with improvement in acne and hirsutism like symptoms.   Total testosterone, and follicle stimulating hormone (FSH) and insulin resistance by Homa- IR, Total Antioxidant Capacity (TAC), Glutathione (GSH).
 
 
Secondary Outcome  
Outcome  TimePoints 
Hirsutism and acne may be improved in adults as well as adolescents.  Acne and Hirsutism. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3/ Phase 4 
Date of First Enrollment (India)   05/09/2022 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   The data will be published without any inconvenience to the patients and without disclosing their personal information. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

According to the Rotterdam PCOS criteria, the prevalence of PCOS in India is 22.5%. At present, combined oral contraceptive (COC) is an effective method for the treatment of PCOS. The limitations of 2nd and 3rd generation COC are that they have side effects like acne and weight gain. Use of fourth-generation COC containing ethinylestradiol (EE) together with a novel progestin, drospirenone (DRSP), have claimed to have properties closer to those of natural progesterone, including anti-mineralocorticoid and anti-androgenic activities and thereby, decrease in acne formation. Vitamin E, which is critically important in the whole process of reproduction, can antagonize the oxidative stress caused by the oxygen free radicals and antioxidant imbalance and regulate normal physiological function of the reproductive system. Subjects who are diagnosed with polycystic ovarian syndrome (PCOS) according to Rotterdam criteria will be recruited. Informed consent will be obtained from all the participants. Randomization will be done in three groups by computer generated software program. Group 1 (DRSP) will be administered with 4th generation combined oral contraceptives (COC) that is drospirenone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24consecutive days with 4 days placebo tablets days (1 cycle) for period of 3 months. Group 2 (DRSP+ E2) will be administered with 4th generation combined oral contraceptives (COC) that is drosperinone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24 consecutive days with 4 days placebo tablets days (1 cycle) and vitamin E200mg once daily for the period of 3 months. Group 3 (DRSP+ E4) will be administered with 4th generation combined oral contraceptives (COC) that is drosperinone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24 consecutive days with 4 days placebo tablets days (1 cycle) and vitamin E 400mg once daily for the period of 3 months. Group 4 (Adolescent) will be administered with vitamin E 400mg once daily for the period of 3 months. All the demographic characteristics and baseline parameters will be recorded. Total testosterone, and follicle stimulating hormone (FSH) and insulin resistance will be examined in 2 months and 3 months. In Oxidative stress, Total Antioxidant Capacity (TAC) will be measured by colorimetric assay at absorbance 570nm, and Glutathione (GSH) will be measured by colorimeter at absorbance 412 nm will be measured by HPLC. All oxidative stress parameters will be determined after 3 months.

 
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