Centchroman - A novel drug for D U B
                     Centchroman - A novel drug for D U B. 
Sudha Prasad 
Maulana Azad Medical College & Associated Lok Nayak Hospital , New Delhi - 110 002. 
Summary: Prospective study of 70 cases of DUB diagnosed after following certain exclusion criteria were 
recruited. Abnormal endometrial pattern was excluded in perimenopausal patients. All the patients were 
followed-up on tablet Centchroman 30 mg. bi-weekly for 6 months. Eighty percent of patients were relieved 
of menorrhagia at the end of the treatment. Majority of patients (90 %) reverted to their normal cycle by 4'" 
month. The incidence of amenorrhoea and oligomenoiThoea wet·e observed in 4.2 % and 5.7 % of patients 
respectively. No abnormal effect was seen on endometrium after the treatment. Side effects were few and 
were well tolerated by the patients. Centchroman was found to be vet·y effective in controlling the symptoms 
'OfD U B. 
Introduction endometri os is, palpabl e fi bro id s and pe lvic infl amm atory 
di seases were exc luded from the study . 
Abnormal ute rine b leedin g is one of the mos t comm on 
problems which is seen in routine G ynaec prac ti ce. It The total durati on of the trial was of 6 month ~ for eac h 
may rep re~e nt a norma l phys io logica l state or it can be a pati ent. The scheduled dose of 30 mg Centch roman was 
sign of a se ri ous underl y ing conditi on. Cause of abnormal g iven biweekly for 6 months to each pati ent . 
uterin e b leedin g sho uld be ascertained qui c kl y a nd 
app ropri ate therapy in stituted. A detailed sys temic and gy naeco logical examina ti on was 
carried out initially. Subsequentl y, o n every vis it, i.e. 
T he treatment o f DUB compri ses of admini strati on o f every month , a deta iled inquiry into the menstrua l patte rn , 
s teroida l h o rm o n e~. lik e proges te ro ne o r O Cs a nd ro utin e phys ical examin ati on, pe lvic examinati on and 
Danazo l. Centchroman is a wide ly used non-stero ida l ora l sonograph y were pe rfo rmed . Routine haemato logica l 
contracepti ve . Thi s agent is developed at Centra l D rug in ves ti gation s and e ndome tri a l aspira ti on were done. 
Tn sti tute , Lu c kn ow in 19 6 7. It ex hibit s uniqu e Whene ver indicated , pelvi c sonography was re peated . 
combinati on o f weak estrogenic and pote nt anti estrogeni c Drugs we re provided to each pati e nt for a mo nth afte r 
acti vities, so it o ffers endometrial suppress ion. Therefore, each ex aminati on. 
it p rotec ts aga in s t e nd o m e tri a l h y pe rp las i a and 
endometria l carc inoma. It al so cures the abnormal uterine A diag nosti c cure ttage was pe rfo rm ed in a ll case~ of 
bleedi ng patte rn . pe rim e n o p a u s al bl eedin g . In c a se o f a bn o rm a l 
hi stopathological findin gs , the pati ent was exc luded from 
Thi ~ pros pecti ve stud y was conducted to observe the the trial. 
efficacy and sa fety o f thi s drug. 
S e ve nty-s ix pati e nts we re se lec te d as D UB fr o m 
Materials and methods G ynaecological Out Pa ti e nt De partment. Si x pati e nts 
we re excluded from the trial as they were not fulfullin g 
A deta il ed protoco l and case record fo rm was deve loped the crite ria . Observation s were tabul ated and di scussed . 
fo r the studi es. The pa ti e nts di agnosed of DUB , afte r 
re mova l o f IUCD a nd pe rim eno pa us al DUB we re Observations and discussions 
eluded in the study. Pati e nts with ute rine si ze more than 
•~?ht weeks, adnexal mass o r tenderness , active heavy In the present ongo ing study a total of 70 pati ents ha ve 
.... ieedi ng necess itating e me rgency treatme nt, breast o r co mpl e te d 6 m o nth s fo ll ow -up . T h e c ri te ri a fo r 
ge ni ta l tract ma li g nanc y, bleeding due to pregnan cy impro ve me nt o f th e co nditi o n was c han ge in th e 
compli cati ons e .g. ves ic ul ar mo le/incomple te aborti ons; menstrua l patte rn . Si xty pe rcent of pati ents we re of 35-
wo men with an y ev id ence of he pati c. re nal , cardi ac 45 years of age group (Table-I). Amount o f bleeding from 
metaboli c dysfunc tion, lactating mothe rs; acti ve venerea l " heavy to norm a l" was the subj ecti ve ap prec iati o n by 
diseases ; in fe rt ility with m e n s trual probl e m s, the pati ent herse lf. Seventy-e ight pe rcent pati e nts we re 
CHE JOURNAL OF OBSTETR ICS AN D GYNAECOLOGY OF INDI A 
Sudha Prasad Centchroman - a novel drug for DUB 
~atisfied by the J3'h week of treatment. Pathology was confirmed histopathologically. 
Table - I Majority of patients (90%) reverted to their normal cycle 
Demographic Profile of Treated Patients by 4 'h month of Centchroman. Incidence of amenorrhoea 
Age (in yrs) o . Percentage and oligomenorrhoea were observed in 4.2o/c and 5.7% 
25-35 20 28.5 of patients respectively which was the only limitation of 
35-45 -1-2 60.0 this drug. There was no incidence of breakthrough 
-1-6-55 8 11.4 bleeding. 
Majority ( 80 o/c ) of patients were relieved of menorrhagia Patients with Centchroman had also usual side effects 
at the end o f treatment (Table II). Amount of bleeding mainly abdominal pain & giddiness (Table VI) . Ten 
could not be assessed as patients used home made napkins percent of patients had abdominal pain, giddiness was 
or clothes of different sizes. observed in 54% of patients. All these patients were 
followed-up and no neurological cause was found. No 
Table - TI patient was observed with weight gain , acn e or nausea/ 
Distribution of patients who responded to vomiting. 
menorrhagia in relation with duration of 
centchroman therapy Inspire of all these minor side effects Centchroman was 
Responded patients Duration of treatment greatly acceptable by the patients . 
(Weeks wise) 
lst 13'h 25 'h On sonography and histopathology, endometrial pattern 
o. of patients 15 55 56 was correlating with endometrial dating. The secretory 
Pe rcentage 21.4 78 .5 80 phase was found in 43 patients (61.4%) whereas decidual 
pattern were seen in 20 patients (28.5o/c). It indicates that 
Pre sence o l cl ot in the menstrual loss is a very easily Centchroman does not interfere with the hypothalamo-
di~cernible aspect of the symptoms and also is a parameter pituitary-ovarian axis. 
of severity of the pathology. In this study, 59 patients 
(8-1-.2 lk) reported presence of clot (Table-IIl) Forty six Post-therapy, endometrium did not reveal any 
pati ents (77 .9 Ck ) were relieved of dysmenorrhoea by the pathological pattern. It proves that it does not interfere 
e nd o f the treatment, whereas I 0 patients have not with ovulation. This is also documented by others (Nigam 
re-; ponded and so dysmenorrhoea persisted in 17 o/c of eta!, 1985 ; Singh and Kamboj 1991 ). Administration of 
1 
patients . Three pati ents ( 59r ) have shown the indication Centchroman in a dose of 1 mg and 2 .5 mg/kg on Rhesus 
of increased dysmenorrhoea. Out of these three patients, monkeys , did not affect the general pattern of plasma 
tvv o had fibroid ute rus which was somehow missed. One LH, FSH, estradiol and progesterone. It indicates again 
patie nt had a pendunculated submucous fibroid of 7 c.m. that Centchroman has no effect on hypothalamo-pituitary-
in size. Other