| CTRI Number |
CTRI/2024/02/062442 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Clomiphene Citrate in improving Sexual Function |
|
Scientific Title of Study
|
Role Of Clomiphene Citrate In Improving Sexual Function In Hypogonadal Men: A Prospective Cohort Study |
| 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 Tejas Gundewar |
| Designation |
Chief Male and Female Fertility Specialist |
| Affiliation |
Ruby Hall Clinic |
| Address |
Room No4, Department of IVF and Endoscopy, 2nd Floor, Building no 4, Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9970054337 |
| Fax |
|
| Email |
tejasgundewar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejas Gundewar |
| Designation |
Chief Male and Female Fertility Specialist |
| Affiliation |
Ruby Hall Clinic |
| Address |
Room No4, Department of IVF and Endoscopy, 2nd Floor, Building no 4, Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9970054337 |
| Fax |
|
| Email |
tejasgundewar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejas Gundewar |
| Designation |
Chief Male and Female Fertility Specialist |
| Affiliation |
Ruby Hall Clinic |
| Address |
Room No4, Department of IVF and Endoscopy, 2nd Floor, Building no 4, Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9970054337 |
| Fax |
|
| Email |
tejasgundewar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Tejas Gundewar |
| Address |
Room No 4, Department of IVF and Endoscopy, 2nd floor, Building no 4, Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshan SM |
RUBY HALL CLINIC |
301, T2A
Godrej Infinity, Keshav Nagar
Pune
MAHARASHTRA |
9538551843
darsh651@gmail.com |
| Dr Tejas Gundewar |
Ruby Hall Clinic |
Room No 4, Department of IVF and Endoscopy, 2nd floor, Building no 4, Ruby Hall Clinic, 40, Sassoon Road, Sangamwadi, Pune
Pune
MAHARASHTRA |
9970054337
tejasgundewar87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N538||Other male sexual dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Hypogonadal men with Sexual Dysfunction
Age 18-75 years
Willing to be a part of the study
Serum Testosterone level <300ng/dl
Serum LH between 1.2 -8 IU/L |
|
| ExclusionCriteria |
| Details |
Hyperprolactinaemia
Diabetes Mellitus
Age <18 or >75 years
Not willing to be a part of the study
Baseline Serum Testosterone ≥300 ng/dL
Men with Hypergonadotropic Hypogonadism (FSH >8IU/L, LH >8IU/L)
Men with Hypogonadotropic Hypogonadism (FSH <1.2 IU/L, LH <1.2IU/L)
CC allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Clomiphene Citrate on Erectile Function in men with sexual dysfunction and IIEF-15 score. |
At baseline, 4weeks and 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Serum Total Testosterone level.
To study the effect of Clomiphene Citrate on orgasmic function.
To study the effect of Clomiphene Citrate on sexual desire.
To study the effect of Clomiphene Citrate on intercourse satisfaction.
To study the effect of Clomiphene Citrate on overall satisfaction. |
At baseline, 4weeks & 8weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/02/2024 |
| 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 Yet Recruiting |
| 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
|
The current study will be conducted in the IVF and Endoscopy Department, Ruby Hall clinic, Pune. All the men attending the IVF OPD between November 2023- November 2024 with Sexual Dysfunction will be assessed by IIEF-15 questionnaire after the detailed history. General physical examination and local examination will be done as a part of initial workup by an Andrologist to avoid inter-observer variability and attention will be given to note testicular size. Hormonal profile (S.Testosterone, S.Prolactin, HbA1c) will be done. S.Testosterone, <300 ng/dl as per the cut-off for hypo-androgenism, will be followed by testing for Serum Follicle Stimulating Hormone (S.FSH) and Serum Leutinizing Hormone (S.LH) to differentiate between hypothalamic, pituitary or testicular dysfunction. Those with serum testosterone < 300 ng/dl and normal FSH and LH will be given a 3-month course of 25mg CC daily. Improvement in IIEF-15 score & S.Testosterone will be assessed at 6weeks and 3 months of drug intake and the data will be recorded in a preset format. |