RESTRICTED PHASE III
CLINICAL TRIAL OF RISUG EXTENDED
The Union Minister
for Health & Family Welfare took a review meeting of the recommendations
of the Monitoring Committee of ICMR that has been constituted
to oversee the progress of trials of injectable male contraceptive,
RISUG. The meeting was attended by Secretary (FW), Secretary (Health),
DGHS, DG (ICMR) and Dr. Guha. The Minister was informed that the
research has not be stalled and the restricted phase III clinical
trial which expired on March 2002 has already been extended upto
April 2003. The results of the analysis of the 141 subjects recruited
and followed upto 6 months will be completed in December 2002.
Minister and Secretary (FW) assured Dr. Guha that funds will be
provided for toxicological studies including genotoxicity and
mutagenecity.
It may be recalled
that the approval for restricted Phase III clinical trial for
proving efficacy of injectable male contraceptive (Styrene maleic
anhydride acopolynus dissolved Dimethyl sulpoxide) developed by
IIT Delhi was given in March 1999 for a period of 3 years with
funding from the Department of Family Welfare by DCG(I). The discipline
of phase III clinical trials require that the researcher himself
should not directly associate with the conduct of trials so as
to maintain total objectivity. Accordingly ICMR has been designated
as the coordinator and the trials are carried out in LNJP Hospital,
Deen Dayal Upadhay Hospital and Rural Hospital, Mehrauli, New
Delhl. The progress of the trials is reviewed by a Monitoring
Committee. The Monitoring Committee met in June 2002 to review
the progress of 141 subjects recruited and 63 subjects who have
been followed up for 6 months. Preliminarily analysis was presented
on the 63 subjects.
The Toxicological
review panel of ICMR for reversibility study of RISUG also had
a meeting in June 2002. The Committee observed that Dimethyle
Sulphoxide used for solvent of Styrene maleic anhydride is a strong
detergent and damages kidney, seen as albumin in urine causing
sub clinical glomerulitis. Since it is known for its toxicity
the side effects are to be monitored.
The Monitoring Committee
has recommended that drug dossier as per Schedule "Y"
requirements should be prepared and evaluated before taking up
more cases for clinical trials. Accordingly Dr. Guha was advised
to follow the recommendation of the Toxicological Review Panel
to review the 141 subjects recruited and allow analysis done.
