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Health Ministry assessing clinical trial findings on injectable contraceptives
Joseph Alexander, New Delhi | Tuesday, June 12, 2007, 08:00 Hrs  [IST]

The Union Health Ministry is evaluating the results of clinical studies conducted by the Indian Council of Medical Research on monthly injectable contraceptives like Cyclofem and NET-EN. The ministry may not take a decision about using them for national family planning programme in the immediate future.

The study on Cyclofem, conducted through its network of Human Reproduction Research Centres (HRRCSs), has been just concluded and the final report on findings is under evaluation. The Ministry sources said that it was too early to decide about its using for national programmes, notwithstanding the good response from the participants in the trials.

A total of 63,754 women, attended family planning clinics at 15 HRRCs, were given a balanced presentation of all the contraceptive methods available in the national programme. Out of these 26,856 (42.3%) accepted tubectomy, 116 (0.2%) couples opted for the vasectomy, 25 per cent accepted condoms, 15.8 per cent accepted IUD, 14.7 per cent accepted oral pills and monthly injectable Cyclofem was opted by 1330 (2.1%) of total family planning seekers.
"A total of 1330 women have been enrolled in the study and observed for 11518 women months of use. Mean age of acceptors is 26.0+4.1 years and mean parity of 18+1.0. Mean weight and height of acceptors is recorded as 48.2+10.9 kgs and 152.3+17.7 cms respectively. 87 per cent of the acceptors are literate and 17.8 per cent are employed. As many as 539 women have used 12 injections. The continuation rates at 6, 9 and 12 months are 79.2, 73.9 and 70.3 per 100 users respectively," the report said.

The ICMR has also been carrying out studies with injectable contraceptive Northisterone Oenanthate since early 80s in different doses and in combination with Oestogen. The phase-III clinical trials were also concluded successfully in this regard, sources said.
Meanwhile, another multicentre study on two-monthly injectable contraceptive Norethisterone Enathate, involving 1209 women across the country and piloted by a Mumbai-based institute under the ICMR, is also nearing completion.

The objectives of the study were to assess user acceptability and continuation rates of this injection, to study side effects and also women's views and attitudes towards injectable contraceptives. The observations based on 17268 months of injection use show cumulative continuation rates at the end of 12, 18 and 24 months as 65 per cent, 53.6 per cent and 48.3 per cent respectively.

Over 79 per cent women were satisfied with the method. About 89 per cent said that the injectable should be available in our national programme and also 79 per cent of them would recommend this method to their friends and relatives. The method was acceptable by the majority of women and was found very effective, the cumulative method failure rate was 0.3 per cent at the end of one year.

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