A pill too hard to swallow?

The male contraceptive answer to the female pill seems as far away as ever, with two pharmaceutical firms deciding to abandon…

The male contraceptive answer to the female pill seems as far away as ever, with two pharmaceutical firms deciding to abandon their research projects. Ali Bracken reports.

The latest clinical trials by two pharmaceutical companies trying to introduce a male contraceptive to the market equivalent to the female pill have abandoned their research. It is the latest failure in more than 15 years of research attempting to develop a male contraception pill, implant or injection.

So what's the hold-up?

"Well, women produce one egg a month whereas men produce three million sperm a day, so it's more of a challenge," explains Dr Maureen Cronin, head of scientific affairs and business communication at Schering, which, along with pharmaceutical company Organon, have decided not to back the final stage of trials into an contraceptive implant with supplementary injections for men.

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Schering and Organon have spent millions conducting Europe's largest study into male fertility control over the past two years which saw 350 male volunteers take part in clinical trials in six countries. Schering claims it has developed a product as effective as the female pill but isn't backing the final phase of trials before it would be introduced to the market because it isn't "what men want".

"In terms of efficacy, safety and reversibility, it was a success. We're still analysing data but we expect the efficacy to be between 90 and 95 per cent," says Cronin.

"But we've also discovered in our research that a combination of an implant and an injection doesn't appear to be what men want. It seems they would prefer just one application rather than both. Schering is now going to look just at injections. We remain committed to this because we think there is a strong need for more contraceptive choice in the marketplace."

Volunteers who took part in the trials had an implant containing progestin inserted into their arm for a year that effectively made them sterile. This was supplemented with testosterone injections every 10 weeks.

"The testosterone injections were really just to make sure you didn't turn into a woman after all the progestin. When it was all over, my wife told me she missed her gay husband," says Clint Witchells (40), originally from South Africa but living in Brixton, who took part in Schering and Organon's clinical trials at London's Royal Free Hospital last year.

"I suffered massive mood swings. After the testosterone injection I'd have a raging libido and be strutting around like a peacock. It was good but distracting.

"You don't want to be walking around like a horny teenage boy when you're a 40-year-old man," he says.

"But when the testosterone was waning, just before I'd get the next injection, I'd be weepy and insecure, curling up on the couch and wanting to have girly chats. I also began to watch soaps, which I hate. My wife preferred my more feminine side, she was able to take me shopping."

Witchells decided to volunteer when he saw on BBC television that the trials were close to being abandoned because of a lack of volunteers in Britain.

"We have three kids and I'd been putting off having a vasectomy. My wife can't take the pill and I think it's only fair that men try to share some of the responsibility. I thought, 'a bit of plastic in my arm and I'm sterile, that sounds good'. And then some testosterone injections, I could do with a bit of that."

A self-professed hypochondriac, Witchells says that although he suffered other side effects including night sweats, slight "nut shrinkage", weight loss and gain, he doesn't regret taking part in the clinical trials. But he realises that perhaps he wasn't the perfect candidate. "Look at all the women who can't take the pill. I might have just been more sensitive to this treatment than many of the other volunteers. And we can't forget that these were trials, and I knew what I signed up for. They were trying out different doses of progesterone and testosterone and mine obviously didn't suit me.

"Towards the end, I asked them if my file on adverse side effects was the biggest and they said it was, which didn't surprise me."

Witchells says he didn't mind shooting blanks or the pain of the plastic rod insertion because, "I'd rather say I'm on the rod than I'm on the pill".

Volunteers were told that 14 per cent of them were part of a "dummy group" and all were encouraged to continue with their regular contraceptive methods.

Witchells realises that, as a result, the side effects he experienced may have been psychosomatic, but he doubts it.

Towards the end of the year's trial, Witchells's mood swings elevated to such a level that he was eventually diagnosed with depression and prescribed Prozac. This may not have had anything to do with the trials, he continues, but he recovered from it when the rod insertion was removed and he's now come off Prozac.

The year-long trial was followed by six months of health monitoring, which Witchells says pandered nicely to his hypochondria. His sperm count returned to normal in the weeks after the trial ended.

Cronin says that while volunteers did report some side effects, the overall outcome was that the implant and injection combination was perfectly safe. But since Schering and Organon have abandoned their joint research, she doubts if a male contraceptive equivalent to the female pill will hit the shelves within the next five years.

Aliya Rahim, medical director with the Irish Family Planning Association (IFPA), says there is a common, old-fashioned misconception in Ireland that men wouldn't be responsible enough to take a contraceptive pill or remember to get an injection if it became available. "Saying men aren't responsible enough is like saying they're not good enough to raise children.

"Contraception is a stigma associated with women in Ireland. It's considered by some as a woman's job and it isn't."

Men genuinely want to play their part in the contraceptive process, she says, and when a male contraceptive equivalent to the female pill comes onto the market, it will be a welcome addition.

"Sixty per cent of women in Ireland are not happy with their contraceptive method. That's where the male contraceptive could come in. And women do trust their partners. In one in 20 couples in Ireland the man gets a vasectomy; I think that shows they want to take responsibility."

With 6,000 women travelling from Ireland for abortions each year, Rahim says, a new contraceptive method could help greatly reduce the number of unplanned pregnancies.

As for Witchells, he too hopes that an effective male contraceptive will soon come onto the market catering for men in long-term monogamous relationships. Despite his experience, he doesn't regret taking part in the clinical trials and has even written a book about his experience, The Pill and I, to be published next year.

One positive side effect, he says, was making contact with his feminine side. "It's made me understand what my partner is going through when she has PMT. It's made me a lot more sympathetic.

"Overall, I think I learnt a lot more from getting in touch with my feminine side than I did being horny and angry."