| CTRI Number |
CTRI/2016/10/007367 [Registered on: 14/10/2016] Trial Registered Prospectively |
| Last Modified On: |
30/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Phase III Study to Evaluate the Efficacy and Safety of Recombinant Human FSH of Cadila Healthcare Limited, India as compared to Gonal-F Administered Subcutaneously in Female Patients Undergoing Assisted Reproductive Technology. |
Scientific Title of Study
Modification(s)
|
A Phase III, Randomized, Open-Label, Multiple-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of Recombinant Human FSH of Cadila Healthcare Limited, India as compared to Gonal-F TM Administered Subcutaneously in Female Patients Undergoing Assisted Reproductive Technology. |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| CRL081423, Protocol version 3.0 dated 10 March 2016 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Dharmesh Domadia |
| Address |
Garden View Corporate House No. 8
Opp. AUDA Garden Bodakdev,Ahmedabad
Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev
Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
9879590828 |
| Fax |
9879590828 |
| Email |
ddomadia@claintha.in |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Dharmesh Domadia |
| Address |
Garden View Corporate House No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad
No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
9879590828 |
| Fax |
9879590828 |
| Email |
ddomadia@claintha.in |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Dharmesh Domadia |
| Address |
Garden View Corporate House No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad
No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
9879590828 |
| Fax |
9879590828 |
| Email |
ddomadia@claintha.in |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
REGISTERED OFFICE:
Zydus Research centre,
Sarkhej – Bavla N.H. No.8A, Moraiya,
Tal: Sanand, Dist: Ahmedabad – 382 213,
Gujarat, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka Kriplani |
AIIMS |
Department of Obstetrics and Gynecology
Room 3076, Teaching block, 3rd floor, AIIMS
Ansari nagar, New Delhi – 110029
New Delhi
|
9560408539
kriplanialka@gmail.com |
| Dr Gita Khanna |
Ajanta Research Centre, Ajanta Hospital & IVF Centre |
Ajanta Research Centre, Ajanta Hospital & IVF Centre, First Floor, IVF department
765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226 005, UP, India
Lucknow
|
9335913046
ivfajanta@gmail.com |
| Dr Nayana Patel |
Akanksha Hospital, and Research Institute |
Akanksha Hospital and Research Institute,
Ground floor,
Unit of Sat Kaival Hospital Pvt. Ltd. Opp. Guru Villa Bungalows, Nr. Shrushti English Medium School , Lambhvel- 387310, Dist- Anand, Gujarat,
Anand
|
9825158227
nayana@ivf-surrogate.com |
| Dr Kamalapriya Thiyagarajan |
BhaktiVedanta Hospital & Research Institute |
BhaktiVedanta Hospital & Research Institute, Sristi Complex,Department of Gynecology
Bhaktivedanta swami marg, Mira Road (East), Thane-401 107, Maharashtra, India
Thane
|
8879614447
g.sivaprasad@yahoo.com |
| Dr Tejasvini Patil |
Lifepoint Multispeciality Hospital |
Lifepoint Multispecialty Hospital,First floor, Doctors cabin
145/1,Mumbai Bangalore Highway,Near Hotel Sayaji,Wakad,Pune-411057
Pune
|
8805785215
adhav.tejasvini121@gmail.com |
| Dr Shalini Srivastava |
Om Surgical Centre & Maternity Home |
Om Research Centre, Om Surgical Centre & Maternity Home,Doctors Cabin, Ground Floor
Sa-17/3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Road, Varanasi-221 007, UP, India
Varanasi
|
9839061967
drshalinivns@gmail.com |
| Dr Pallavi Vishwekar |
Padmashree Dr. D.Y Patil Hospital and Research |
Department of Gynecology OPD 60.
Padmashree Dr. D.Y Patil Hospital and Research, Sector no. 5.
Nerul, Navi Mumbai-400706
Mumbai (Suburban)
|
9867355314
drpallavibasapuve@gmail.com |
| Dr Shalini Gainder |
Post graduate institute of Medical Education & Research |
Department of Obstetrics & Gynecology Post graduate institute of Medical Education & Research ,
PO Box 1510, Sector 12, Chandigarh, India
Chandigarh
|
9815555732
sgainder@gmail.com |
| Dr Bharti S Dhorepatil |
Shree Hospital |
Shree Hospital,
Gynecology Department
Siddhartha Mansion, Ground floor, Opp. Agakhan Palace,
Nagar Road, Pune- 411006,
Maharashtra, India
Pune
|
9822043112
bdhorepatil@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Bhakti Vedanta hospital Ethics Committee |
Submittted/Under Review |
| Ethics Committee All India Institute of Medical Sciences |
Approved |
| Ethics Committee of Shree Hospital |
Approved |
| Institutional Ethics Committee Ajanta Research Centre Ajanta Hospital and IVF Centre |
Approved |
| Institutional Ethics Committee Om Research Centre Om Surgical Centre and Maternity Home |
Approved |
| Institutional Ethics Committee Padmashree Dr D Y Patil Medical College and Research Centre |
Approved |
| Institutional Ethics Committee Post Graduate Institute of Medical Education and Research |
Approved |
| Institutional Ethics Committee, Sat Kaival Hospital Pvt. Ltd. |
Approved |
| Life Point Multispecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Undergoing Assisted
Reproductive Technology
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gonal-F |
Gonal-F of Merck Specialties Pvt. Ltd. |
| Intervention |
r-hFSH |
Recombinant Human Follicular Stimulating Hormone of Cadila Healthcare
Limited, India
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1. Females between 22-38 years of age with regular menstrual cycle of 24-35 days
2. Infertile female patients undergoing Controlled Ovarian Hyperstimulation
(COH) for Assisted Reproductive Technology (ART)
3. BMI between 18-30 kg/m2 inclusive
4. Transvaginal ultrasound documenting the presence of both ovaries without
abnormalities and normal uterine adnexa
5. Clinically acceptable ranges of Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2) at the time of enrollment
6. Antral follicle count (AFC) ≥ 8 to ≤ 25 follicles (sum of both ovaries)
7. Willing to comply with all the study requirements and procedures
8. Normal or clinically insignificant haematology, serum chemistry and urinalysis
parameters during screening
9. Willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. History of allergy or hypersensitivity reactions to FSH or any other ingredients of the formulation
2. Use of any FSH preparation or clomiphene citrate within 60 days of randomization
3. History of ≥ 2 succeeding ART retrieval cycles (which includes fresh and frozen embryo transfers before the study cycle without clinical pregnancy
4. Presence of polycystic ovaries (PCO)
5. Previous history of severe ovarian hyperstimulation syndrome
6. Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
7. Presence or history of thrombophlebitis or thromboembolic disorders
8. History of extrauterine pregnancy in the previous 3 months
9. History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
10. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
11. Positive Pap Smear at screening
12. combination or hormonal implants ≤ 6 months prior to screening
13. Positive Pregnancy test at screening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Oocytes retrieved |
Number of Oocytes retrieved |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Biochemical pregnancy rate after 2 weeks of embryo transfer
• Total dose of r-hFSH required
• Number of days of r-hFSH stimulation
• Number and size distribution of follicles at the day of ovulation induction.
• Percentage of patients with need to increase or lower the dose of r-hFSH
• Number of good quality oocytes
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2016 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Brief Summary
|
This study is designed to evaluate efficacy and safety
of the test and reference drug products and To compare Relative
Pharmacokinetics and Immunogenicity of the test and reference drug products
Infertility is currently defined as 1 year of unwanted
non-conception with unprotected intercourse in the fertile phase of the
menstrual cycles. 1 Some of the therapies being currently utilized for treating
infertility are medication therapy, surgical therapy and Assisted Reproductive
Technology (ART). In order to obtain more than one embryo for implantation in females
undergoing ART and thus to improve the chances of a pregnancy, it is necessary
to stimulate the growth and maturation of several follicles by daily
administration of Follicle
Stimulating Hormone (FSH). In a multicentre,
randomized, placebo-controlled, parallel-group, phase III trial, acotiamide
treatment showed significant improvement in symptom severity and eliminated
meal-related symptoms in patients with FD. Clinical trial data indicate that
acotiamide is generally well tolerated. In a long-term 48-week study, FD
symptoms were controlled by intermittent administration of acotiamide even in
patients with relapsing FD and most of the adverse drug reactions were mild in
severity.
The
recombinant human follicle stimulating hormone (r-hFSH) of Cadila Healthcare
Limited has been prepared to ensure high efficacy and safety. This study is
designed to evaluate the efficacy, safety, pharmacokinetics and immunogenicity
of recombinant human FSH of Cadila Healthcare Ltd. with the RLD, Gonal-F and
facilitate its registration and availability in India.
The total number of patients to enroll
is around 116 from India. |
