Logan Whitehead, 24, of Torrance, California, applied a clear gel to his shoulders every morning for a year and a half, waited for it to dry, and then went about his day as usual. The gel, which looked and smelled like hand sanitizer, was a hormonal solution used to prevent sperm production, that is, male birth control.
IT IS CONSIDERED AS THE MOST EFFECTIVE SOLUTION EVER
Whitehead was volunteering in a phase 2 trial of the gel until his participation ended last winter. The product, which contains a synthetic hormone called Nestorone, which reduces testosterone and sperm production, is considered the most advanced among the new birth control options for men.
Whitehead said that if the Food and Drug Administration approves the gel, he would definitely continue using it, especially after watching his wife struggle with current birth control options. “The gel was a very easy process,” Whitehead said. “It was like taking a daily pill.”
HE DID NOT FEEL SIDE EFFECTS
Whitehead said she didn’t notice any side effects while using the gel beyond acne on her upper back and possibly some weight gain, but that may be related to her being inactive at her job.
HORMONAL GEL TRIAL PROMISES HOPE
At the Endocrine Society’s conference in Boston on Sunday, researchers from the National Institutes of Health’s Contraceptive Development Program presented encouraging phase 2 trial results of the hormonal gel.
IT PROVIDED THE EXPECTED FAST RESULT
The trial involved 222 men, ages 18 to 50, who applied 5 milliliters (about a teaspoon) of the gel to each shoulder blade once a day.
The second part of the two-part trial is still ongoing. Initial findings showed the contraceptive worked faster than expected, according to Diana Blithe, chief of NIH’s Contraceptive Development Program.
THE RESULTS ARE SUCCESSFUL FOR THE MAJORITY OF THOSE PARTICIPANTS
After applying the gel every day for 12 weeks, 86% of trial participants achieved sperm suppression. That means they only had up to 1 million sperm per milliliter of semen, which is the amount researchers think is effective for birth control. On average, the timing for effective birth control is eight weeks. In contrast, without birth control, normal sperm counts can range from 15 million to 200 million per millilitre.
IT TOOK LONGER THAN IT USED
The faster-than-expected timing for sperm suppression is an encouraging sign, especially since past attempts took longer to reach those sperm levels, Blithe said in a news release about the new data. Previous trials required higher doses of the hormone, which can cause side effects. Since the new gel contains both testosterone and Nestorone, it acts faster and requires less testosterone.
So far, men in the clinical trial of the gel have shown blood testosterone levels low enough to maintain normal sexual function.
NON-HORMONAL OPTIONS ARE ALSO BEING DEVELOPED
Also on Sunday, YourChoice Therapeutics said a very small trial in the United Kingdom with just 16 men showed that the non-hormonal pill YCT-529 was safe and without side effects. The San Francisco company’s non-hormonal pill works by blocking the vitamin A receptor, which is important for male birth control.
A medical device company called Contraline, based in Charlottesville, Virginia, is also developing a non-hormonal male birth control method that involves injecting a gel into the vas deferens, the tubes that carry sperm from the testicles.
Injecting the gel, called ADAM, involves a single 15-minute procedure, said Kevin Eisenfrats, CEO and co-founder of Contraline. The gel is then intended to remain in place for years.
MOBILE SPERM ARE RESET WITHIN 30 DAYS
Eisenfrats noted that in January, the company reported that among 25 clinical study participants, the trial resulted in a 99.8% to 100% reduction in motile sperm count within 30 days after the procedure.
“It is very similar to the experience patients have after vasectomy. “Some of these patients had mild bruising and swelling, which resolved spontaneously.”
