Male Birth Control: Understanding Options

By Elizabeth Akincilar-Rummer

MEN!!! Are you ready?? Birth Control for men is here….almost.

Contraception. For some of us, that word has been a saving grace in preventing unwanted pregnancies and diseases. For others, it is fraught with moral and ethical dilemmas. But, those who are the most concerned with and often the most involved with contraception, are women. Let’s be real, women, versus men, take the brunt of birth control. And, maybe we should, since we are the ones who would have to endure 40 weeks of pregnancy and the birth of a child. Maybe the responsibility should be primarily on our shoulders. But, what about everything that occurs after the birth of a child? That lifelong responsibility of a child parents accept when they decide to conceive is on both parents, right? So, why wouldn’t the responsibility of birth control be for both the man and the woman? Good question. I think it should. I think we should have a choice. I think a couple should be able to decide, together, who should take on the responsibility of birth control.

Before you get your panties in a bunch, I know what some of you are going to say. You’re thinking, we already have a choice. Men can use a condom, they can use the withdrawal method, or they can undergo a sterilization procedure. Uh huh. Right. As if those are great choices. Let’s look at each option. Studies show that if you use the withdrawal method perfectly, 4 women out of 100 will get pregnant. If it’s done incorrectly, 27 out of 100 women will get pregnant. And, by the way, the withdrawal method is extremely difficult to do correctly if the man doesn’t have excellent self-control, men who ejaculate prematurely, and for men without a significant amount of experience. Condoms are 98% effective when used perfectly. Studies have shown that up to 40% of men use condoms incorrectly. And, sterilization isn’t an option for most couples since many of them will actually want to eventually get pregnant, and sterilization is not easily reversible. Where does that leave us? Not with a good choice, that’s where.

First, let’s just look at some numbers. How popular is birth control? Who uses it? I’ll tell you. Many, many, many women.

99% of sexually active women from 2006 to 2010 in the US used at least one form of contraception¹
12 million women take oral birth control pills each year in the US²
89% of at-risk Catholic women, 90% of at-risk Protestant women, 83% of black women, 91% hispanic and white women, and 90% of asian women in the US use contraception^3,4

What are the available birth control options available for women?

Hormonal methods, such as the pill, patch, injectables, hormonal IUD, and the vaginal ring
Non-hormonal IUD
Read Jandra Mueller’s two-part blog post for the full story on IUDs: part 1 and part 2

What the possible side-effects for hormonal methods of birth control?

Intermenstrual spotting, nausea, breast tenderness, headaches, weight gain, mood changes, decreased libido, vaginal discharge
In some women, dyspareunia and pelvic pain
- Read Dr. Gonzalez’s two-part blog post about the birth control pill, hormones, and pelvic pain: part 1 and part 2
Associated with increased blood pressure, benign liver tumors, and a slight increased chance of developing cervical cancer
Increased risk of heart attacks, stroke and blood clots, which can be fatal

Are there hormonal birth control methods available for men? No.

Is it possible? Yes.

Let’s look at the history behind this curious absence in modern medicine.

Over the last century, many contraceptives have been introduced for women, yet not even one has been commercially introduced for men. Medicine has recognized the need for reversible and reliable birth control for men. It is agreed that a reversible hormonal method that suppresses sperm is the most practical implementation. Although reversible hormonal suppression of spermatogenesis (making sperm) was realized in the 1930’s, the first hormonal studies were only undertaken in the 1970’s. However, these feasibility studies were only further explored in the 1990’s. The studies in the 1990’s showed very effective and reversible sperm suppression, superior to condoms, and comparable to female contraception, with weekly testosterone injections.

In the last four decades, many studies have shown that hormonal suppression of spermatogenesis can prevent pregnancies, but development of commercially available products have stalled. Some of the early studies used supraphysiological doses of testosterone which had potential long-term adverse effects in healthy men. However, later studies found that the testosterone dose can be lowered by co-administering progesterone, essentially. However, there were only two studies that examined that method of administration.

The first study published in 2011 looked at administering progesterone and testosterone via an implant. It prevented 100% of pregnancies and was easily reversible. They did not report any serious adverse effects, but did report a high discontinuation rate among the participating men. This product was only a prototype and was not commercially available; therefore, it would require a significant amount of industrial research and development. They concluded that this study showed that male hormonal contraceptive products are considered medically and scientifically feasible.

The second study also published in 2011 also looked at administering progesterone and testosterone via an implant. They showed that 80% of the men in the study had a sperm count below the threshold of criterion for contraception. It also reported a high discontinuation rate among the participating men. They concluded that this study justified additional studies.

That brings us to the most recent study published in The Journal of Clinical Endocrinology and Metabolism in October 2016. The World Health Organization commissioned a trial that utilized a two hormone intramuscular injection to lower sperm count. The study included 10 study centers, worldwide, with 320 participants, but 100 continued users. They performed two intramuscular injections every eight weeks for up to four injection visits. The initial findings suggested a 96% effective rate with near complete suppression of spermatogenesis. They also showed that most of the participants returned to full fertility on an average of 26 weeks after discontinuing the injections. However, the Stage II Trial was interrupted due to reported side effects. The side effects reported were acne, injection site pain, increased libido, and mood disorders. The incidence of mild to moderate mood disorders was relatively high, but mostly in one of the study centers. Two independent safety committees evaluated the side effects and although they came to different conclusions, the study was terminated early. Since there was a difference in opinions from the two safety committees, the authors of this study feel that there is no definitive answer as to whether the potential risks outweigh the positive benefits in this study. The study also noted that while there is a risk for the men involved, albeit small, it is not a fatal risk, like that women risk by taking the birth control pill because of blood clots. It is important to note that for those that completed the first phase of the trial, more than 75% of the participants reported being satisfied and would be willing to use the product if it was available.

I wonder why one of the safety committees found the side effects so alarming that they had to terminate the study when hormonal birth control drugs for women cause similar and even more dangerous side effects, yet MILLIONS of women take the birth control pill every day. If we really want to compare dollars to donuts, one of the primary reasons this study was terminated was the adverse effect of mood disorders. I wonder if that safety committee is aware of this recent study published in JAMA psychiatry that reported 30% of women taking the birth control pill stopped taking it because of dissatisfaction secondary to side effects. They found that hormonal birth control was linked to a subsequent depression diagnosis and use of antidepressants. They also found a 40% increased risk of depression after six months of birth control pill use.

A few questions come to mind. Maybe safety committees have become more cautious compared to the time when many of the female hormonal drugs were being tested? Why aren’t there more studies examining male hormonal contraceptives? Why are the subject drop out rates so high in all of these studies? Why hasn’t there been any interest in commercially developing a product? Is it because the market research shows that men aren’t actually interested in such a product? Is there such a significant gender bias regarding birth control in our culture that there isn’t motivation to develop this product?
It seems that male hormonal contraception should already be a reality, but surprisingly, it’s not. I think a lot of women are more than ready to share the burden of contraception. The real question is, men, are you ready?

References:

Daniels K, Mosher WD and Jones J, Contraceptive methods women have ever used: United States, 1982–2010, National Health Statistics Reports, 2013, No. 62
WebMD, Comparing birth control pill types, accessed 26 February 2015.
Jones J, Mosher WD and Daniels K, Current contraceptive use in the United States, 2006–2010, and changes in patterns of use since 1995, National Health Statistics Reports, 2012, No. 60
Jones RK and Dreweke J, Countering Conventional Wisdom: New Evidence on Religion and Contraceptive Use, New York: Guttmacher Institute, 2011.

FAQ

What are pelvic floor muscles?

The pelvic floor muscles are a group of muscles that run from the coccyx to the pubic bone. They are part of the core, helping to support our entire body as well as providing support for the bowel, bladder and uterus. These muscles help us maintain bowel and bladder control and are involved in sexual pleasure and orgasm. The technical name of the pelvic floor muscles is the Levator Ani muscle group. The pudendal nerve, the levator ani nerve, and branches from the S2 – S4 nerve roots innervate the pelvic floor muscles. They are under voluntary and autonomic control, which is a unique feature only they possess compared to other muscle groups.

What is pelvic floor physical therapy?

Pelvic floor physical therapy is a specialized area of physical therapy. Currently, physical therapists need advanced post-graduate education to be able to help people with pelvic floor dysfunction because pelvic floor disorders are not yet being taught in standard physical therapy curricula. The Pelvic Health and Rehabilitation Center provides extensive training for our staff because we recognize the limitations of physical therapy education in this unique area.

What happens at pelvic floor therapy?

During an evaluation for pelvic floor dysfunction the physical therapist will take a detailed history. Following the history the physical therapist will leave the room to allow the patient to change and drape themselves. The physical therapist will return to the room and using gloved hands will perform an external and internal manual assessment of the pelvic floor and girdle muscles. The physical therapist will once again leave the room and allow the patient to dress. Following the manual examination there may also be an examination of strength, motor control, and overall biomechanics and neuromuscular control. The physical therapist will then communicate the findings to the patient and together with their patient they establish an assessment, short term and long term goals and a treatment plan. Typically people with pelvic floor dysfunction are seen one time per week for one hour for varying amounts of time based on the severity and chronicity of the disease. A home exercise program will be established and the physical therapist will help coordinate other providers on the treatment team. Typically patients are seen for 3 months to a year.

What is pudendal neuralgia and how is it treated?

Pudendal Neuralgia is a clinical diagnosis that means pain in the sensory distribution of the pudendal nerve. The pudendal nerve is a mixed nerve that exits the S2 – S4 sacral nerve roots, we have a right and left pudendal nerve and each side has three main trunks: the dorsal branch, the perineal branch, and the inferior rectal branch. The branches supply sensation to the clitoris/penis, labia/scrotum, perineum, anus, the distal ⅓ of the urethra and rectum, and the vulva and vestibule. The nerve branches also control the pelvic floor muscles. The pudendal nerve follows a tortuous path through the pelvic floor and girdle, leaving it vulnerable to compression and tension injuries at various points along its path.

Pudendal Neuralgia occurs when the nerve is unable to slide, glide and move normally and as a result, people experience pain in some or all of the above-mentioned areas. Pelvic floor physical therapy plays a crucial role in identifying the mechanical impairments that are affecting the nerve. The physical therapy treatment plan is designed to restore normal neural function. Patients with pudendal neuralgia require pelvic floor physical therapy and may also benefit from medical management that includes pharmaceuticals and procedures such as pudendal nerve blocks or botox injections.

What is interstitial cystitis and how is it treated?

Interstitial Cystitis is a clinical diagnosis characterized by irritative bladder symptoms such as urinary urgency, frequency, and hesitancy in the absence of infection. Research has shown the majority of patients who meet the clinical definition have pelvic floor dysfunction and myalgia. Therefore, the American Urologic Association recommends pelvic floor physical therapy as first-line treatment for Interstitial Cystitis. Patients will benefit from pelvic floor physical therapy and may also benefit from pharmacologic management or medical procedures such as bladder instillations.

Who is the Pelvic Health and Rehabilitation Team?

The Pelvic Health and Rehabilitation Center was founded by Elizabeth Akincilar and Stephanie Prendergast in 2006, they have been treating people with pelvic floor disorders since 2001. They were trained and mentored by a medical doctor and quickly became experts in treating pelvic floor disorders. They began creating courses and sharing their knowledge around the world. They expanded to 11 locations in the United States and developed a residency style training program for their employees with ongoing weekly mentoring. The physical therapists who work at PHRC have undergone more training than the majority of pelvic floor physical therapists and as a result offer efficient and high quality care.

How many years of experience do we have?

Stephanie and Liz have 24 years of experience and help each and every team member become an expert in the field through their training and mentoring program.

Why PHRC versus anyone else?

PHRC is unique because of the specific focus on pelvic floor disorders and the leadership at our company. We are constantly lecturing, teaching, and staying ahead of the curve with our connections to medical experts and emerging experts. As a result, we are able to efficiently and effectively help our patients restore their pelvic health.

Do we treat men for pelvic floor therapy?

The Pelvic Health and Rehabilitation Center is unique in that the Cofounders have always treated people of all genders and therefore have trained the team members and staff the same way. Many pelvic floor physical therapists focus solely on people with vulvas, this is not the case here.

Do I need pelvic floor therapy forever?

The majority of people with pelvic floor dysfunction will undergo pelvic floor physical therapy for a set amount of time based on their goals. Every 6 -8 weeks goals will be re-established based on the physical improvements and remaining physical impairments. Most patients will achieve their goals in 3 – 6 months. If there are complicating medical or untreated comorbidities some patients will be in therapy longer.