| 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
|
|
|
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
|
|
|
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. |