Male birth control gel trial comes to Nairobi
Are you a man aged between 18 and 50? Are you sexually active and in a steady monogamous relationship? And finally, have you ever pictured yourself as the one carrying the burden of family planning in the relationship?
Well, an exciting global study on male contraception is happening right here in Kenya, and you are invited to enrol.
All the men in the experiment, a phase-two clinical trial, will be required to apply a gel on their shoulders. This gel is supposed to lower the sperm count to a point where they cannot impregnate a woman.
The gel being tested is composed of the hormone nestorone, a progestin hormone commonly used for female contraception and testosterone. The combination gel, referred to as the NES/T within the technical group, is a novel, reversible contraceptive for men designed to be absorbed through the skin on the upper arms and shoulders.
The men in Kenya will join others around the world in using the daily gel for up to 52 weeks to drop the sperm count to zero.
The gel formulation was developed by the Population Council and the US National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Kenya is the first African country to be chosen for a study of the sort, according to Dr John Kinuthia, the Kenya site principle investigator for the study. Kenya’s NICHD’s Contraceptive Clinical Trials Network (CCTN) site is at Kenyatta National Hospital (KNH).
The trial committee will enlist up to 60 couples from Kenya for the study. Globally, more than 420 couples will be recruited to take part in the trial.
The sites have already launched in Los Angeles, Seattle and Kansas City in the US. Kenya, Chile, England, Italy, Scotland and Sweden are preparing to start the trial within the next month.
“We have done all the regulatory approvals but we’re still in the preparatory stages. Once we are ready in the next couple of weeks we will start enrolling our participants here at KNH,” he said during an interview with the Nation at KNH.
The gel has been touted as the most promising new method of male birth control. Others that have previously been on trial have been the male pill and an injection.
This is the second phase of a trial of the topical gel’s ability to prevent pregnancy. The first phase of clinical trials to test the safety and efficacy of the gel was done in the US last year.
“Initial studies done so far show that it does not reduce libido or cause adverse skin issues,” said Dr Kinuthia.
“The gel needs to effectively suppress spermatogenesis (or maturation of spermatozoa within the male reproductive organs, to a point whereby fertilisation does not occur,” he notes.
‘MINIMAL SIDE EFFECTS’
“But importantly, we are testing to ensure that it has none or very minimal side effects,” adds the doctor.
The men in the study must intend to remain in the relationship for at least two years, according to Dr Kinuthia.
“This is because we will be examining them for two years. The phase where we are evaluating the drug will be one year, but we need a period pre-drug use for examination of the participants and preparation for one to be in the study and then suppress the sperms for the one year and then a recovery period after the use of the drug where we’ll be checking that the sperm production has returned to normal,” he explained.
The development of an effective male contraceptive has for a long time been the white whale of reproductive health scientists eager to allow men the same stake in birth control.
Currently, the most common birth control methods for men are condoms, vasectomy and withdrawal during sex.
According to the Population Council in New York, results from the NES/T gel trial are expected in 2022.