Efficacy and Safety of Ultra Low Dose Oral Contraceptive Pills in Rural Indian Women - A Prospective, Open Label Study

Abstract

Sheela Raghavendra Sharma1

BACKGROUND
Combined oral contraceptive pills are the most effective temporary contraception
methods and are used by approximately 60 - 80 million eligible women throughout
the world. It is the oestrogen component of the combined oral contraceptive (COC)
which is responsible for the undesirable and serious side effects such as deep vein
thrombosis (DVT) and pulmonary embolism (PE). So, there has been a constant
effort to reduce the amount of ethinyl estradiol (EE) while maintaining its
contraceptive efficacy. This study was aimed at studying the safety and efficacy
of ultralow dose combined oral contraceptive (containing 15 mcg EE + 60 mcg
gestodene) in rural Indian women.
METHODS
The study was done at Rama Medical College, Mandhana, Kanpur, among 70
patients who fulfilled the inclusion criteria. The patients were given ULDOCP and
followed up for 6 months. The patients followed the regime of one tablet of
ULDOCP daily from day 1 to day 24 of the menstrual cycle with 4 days pill free
period before starting the next pack.
RESULTS
Seventy patients completed the study till 3 months and fifty patients completed
the study till 6 months. Break through bleeding (BTB) was the only prominent side
effect which was reduced in subsequent cycles and our patients tolerated this well.
No pregnancy resulted. The ULDCOP was very well accepted by those women who
were counselled about possible side effects and their harmless nature before
starting the study. It was found that the users were satisfied with the use of
ULDOCP. All side effects were significantly lower after 2 months of use and there
were no serious side effects.
CONCLUSIONS
The 24 / 4 ULDOCP regimen seems to be a safe and effective contraceptive
method for use in rural population after properly counselling them. The reduced
pill free interval of 4 days offered additional advantages.

image