The need for a safer alternative to Progestogen - Estrogen combination pills has
been felt ever since the sixties. Clearer understanding of the role of
estrogen-progesterone balance in the development of fertilized ovum and the
priming of the uterus for implantation served as the basis for developing an agent
that would prevent pregnancy by interfering with implantation but without disturbing
the hypothalamus-pituitary-ovarian axis. Researchers the world over have been
designing and synthesising non-steroidal estrogen antagonists that would act by
disturbing the delicate balance between estrogen and progesterone at the uterine
level without interfering with their synthesis or blood levels. Centchroman developed
by CDRI precisely does this.
Centchroman is a novel non-steroidal agent unrelated to any conventionally used
contraceptive. This is the only anti-implantation agent approved for clinical use in
the world. It offers a unique combination of weak estrogenic and potent
antiestrogenic properties. Due to this subtle mix of estrogenic and antiestorgenic
action it inhibits the fertilized ovum from nidation and thus prevents pregnancy, but
at the same time it does not appear to disturb the other estrogen effects.
Use of Centchroman as a contraceptive has been extensively evaluated in more
than 2000 women of the reproductive age groups who wanted to space their
children. Intensive monitoring by clinical examination, haematology and
biochemical tests as well as laparascopy and ultrasonographic examinations of
ovaries and uterus have shown the drug to be quite safe. Centchroman does not
cause nausea, vomiting, dizziness and break through bleeding and has no adverse
effect on lipid profile and platelet function as is seen with steroidal contraceptives.
Babies born to use failure cases have shown normal milestones. The contraceptive
effect is readily reversible and subsequent pregnancy and its outcome is normal. It
scores over steroidal contraceptive pills because it does not disturb the endocrine
system and the normal ovulatory cycle is maintained.
Centchroman has been licensed to two companies in India.
Hindustan Latex Ltd., Trivandrum, which is marketing it under the trade name,
Saheli.
Torrent Pharmaceuticals Ltd, Ahmedabad, which marketed it under the trade
name, Centron.
Centchroman as an antibreast cancer agent
Centchroman has also been found effective as an anti-breast cancer agent.
Multicentric trials in stage III/IV breast cancer patients, who were not responsive to
other modalities of therapy, were found to respond to Centchroman with an overall
responsive rate of about 56%. The data is being compiled for seeking marketing
permission from DCG(I).