Shouldering the responsibility: Male birth control absorbed through skin

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Komkrich007)
(Image: Getty/Komkrich007)

Related tags: male birth control, Drug delivery, formulation, Clinical trial, Hormone, Testosterone

A clinical trial has begun to test the safety and efficacy of male birth control in a drug delivered through application on the arms and shoulders.

The first clinical trial testing the safety and efficacy of Nestorone (segesterone acetate), a gel formulation of male birth control, has been launched across three sites.

Nestorone, comprised of progestin and testosterone, is a reversible contraceptive for men, absorbed through the skin of the upper arms and shoulders. Its formulation is designed to reduce the production of sperm without impacting the ability to produce sperm later in life.

Regine Sitruk-Ware, co-director of the study and scientist at the population council, told us that the formulation acts on the pituitary gland and blocks the production of the hormone that triggers sperm production while hindering testosterone. “The combination of both acts in concert to stop the production of sperm, while minimizing side effects,”​ she explained.

When applied to the skin, the gel helps to introduce the dissolved hormones into the skin that work as a “reservoir from which the hormones are diffused through the vessels under the skin,”​ Sitruk-Ware told us. Through the blood vessels, the drug reaches the circulatory system and is distributed to the whole body.

According to Sitruk-Ware, the shoulders are used as the application site since the skin surface is large enough to receive the 5ml of gel.

The man’s sperm count must reach an appropriate level to prevent pregnancy, which takes approximately eight to 16 weeks of use.

The treatment is currently in a Phase IIb trial, sponsored by the National Institute of Child Health and Human Development and run by the organization’s Contraceptive Clinical Trials network – it is the first to test the product for contraceptive efficacy in a female partner. Approximately 400 couples are anticipated to enroll in the trial, with the efficacy being tested for a full year’s course of treatment.

Nestorone is not the first sperm production inhibitor drug candidate to be researched. In 2012, a team at Texas A&M University found that the compound JQ1​ successfully inhibited the production of sperm and worked to reduce sperm mobility without affecting hormone levels.

More recently, a study published in American Chemical Society’s Journal of Medicinal Chemistry found an extract​ that interrupts the passage of sperm cells needed to fertilize an egg. This extract is another reversible contraceptive that does not affect hormone levels.

Related news

Show more

Related products

show more

A Better Approach, for Better Pain Trials

A Better Approach, for Better Pain Trials

Signant Health | 27-Sep-2021 | Technical / White Paper

Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us

Products

View more

Webinars