Commentary Contraception

Male Birth Control Study Should Prompt Calls for More Research, Not Mockery

Martha Kempner

It is appropriate for a study of a new drug to be shut down if the participants (be they male or female) are suffering. Also, side effects of birth control should not be inevitable for women either.

Recently, articles reported that despite the success of an injectable male contraceptive in preventing pregnancy, a multiyear study of the drug was shut down because its side effects—including mood swings, acne, and heart palpitations—were too severe. The internet immediately lit up with responses pointing out just how long women have been putting up with these same symptoms without missing a beat, and implying that men must be wimpy by comparison.

Many of these articles missed two important points. First, it is appropriate for a study of a new drug to be shut down if the participants (be they male or female) are suffering. Also, side effects of birth control should not be inevitable for women either. Any woman who is experiencing mood swings, acne, breast tenderness, or other symptoms due to her chosen method should also consider talking to her health-care provider about alternatives.

Male Study Shut Down Due to Side Effects

The study, published in the October issue of the Journal of Clinical Endocrinology & Metabolism, recruited 324 men between the ages of 18 and 45 from multiple sites. To qualify, the men had to have normal sperm counts and be in monogamous, heterosexual relationships with women between the ages of 18 and 38. Participants were given two injections, made up of types of the hormones progestin and testosterone, every eight weeks. They were then tested at eight weeks, 12 weeks, and every two weeks after that, until their sperm count was below one million per milliliter. At that point, they were told to stop using other forms of birth control with their partners.

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The injections were successful in reducing sperm count (274 participants met the low sperm count within 24 weeks) and preventing pregnancy (only four pregnancies occurred). However, among the 324 men, there were nearly 1,500 reports of adverse reactions, such as injection site pain, muscle pain, increased libido, acne, and depression. Researchers determined that nearly 40 percent of these—including one suicide—were unrelated to the drug, but that still left a high rate of side effects. For these reasons, researchers decided to stop enrolling new participants in 2011.

As some articles have noted, this decision stands in stark contrast to the original testing protocols for birth control pills. When these were being developed in the 1950s and ’60s, some women test subjects were not informed of what the drugs did; others were told their purpose, but not that they were experimental. Women’s complaints of side effects were ignored, and researchers deliberately looked for populations—such as poor women in Puerto Rico and those confined to mental institutions—who could be coerced or even forced into continuing the study even if they experienced bad side effects. Ultimately, the doctor in charge of the Puerto Rican drug trial concluded that the first pill being tested was 100 percent effective, but that 17 percent of women experienced side effects so severe as to make the tested formulation unacceptable for release to the general public. Despite this conclusion, that version of the pill was released.

It is important to put that study into historical perspective. Birth control and research to develop it were not legal in the United States, and women were desperate for more family planning methods. Moreover, modern requirements for experiments, such as informed consent and institutional review boards, had not yet been implemented, and the FDA did not yet have the authority to insist drugs be safety-tested on animals before they were tested on people.

And while it is also easy to say that the men in this study just weren’t tough enough to handle side effects—many of which women live with on a daily or at least monthly basis—this would be unfair. We want researchers to follow generally agreed-upon precautions, including heeding severe symptoms, and we do not want drugs on the market that cause excessive side effects or ones that are too severe. The researchers were right in halting enrollment until the formulation of the drug could be altered. And the men weren’t wimps—though 20 did drop out of the study because of the side effects, 75 percent said they would continue to take the injections if they could.

Women Don’t Need to Live With Side Effects Either

There’s another fallacy in the suggestion that these men couldn’t handle something women must endure: the idea that all contraceptive methods have inevitable side effects and that we must just grin and bear it. When it comes to birth control, one thing women have that men do not is options. There are many different methods of birth control, and within each method there are choices that may make the difference between being saddled with mood swings and being perfectly content.

The pill is the best example. There are different types of oral contraceptive pills. Most common are combination pills, which contain both estrogen and progestin. They usually come in 28-day packs of which 21 pills contain active ingredients and seven contain a placebo, placeholders for women to take while they have their period so they don’t get out of the habit of taking a pill daily. Some brands contain 24 days of the pill and only four placebo pills, and there are extended-use pills, which are taken for three months at a time with only four breaks a year for a period. Some pills contain the same dose in every active pill (known as monophasic) while others increase a little bit each week throughout the month (multiphasic). There are also those that contain a very low dose of the active ingredients. And, for women who shouldn’t use estrogen, there are “mini pills,” which contain only progestin.

When a person first starts the pill, there may be side effects such as nausea, headaches, weight gain, mood swings, or breast tenderness. These are similar to the symptoms some women get when they have their period, and are a result of the hormone fluctuations.

Often, there are things you can do to feel a little better. If the pill makes you nauseated, for example, take it right before you go to bed so that you’ll be asleep for the worst of it or take it with food to provide some cushion in your stomach. Though this sounds silly, if your breasts are hurting, make sure you are wearing a comfortable bra. And if you’re in pain—headaches or cramps—find a painkiller like ibuprofen or aspirin that works for you.

Symptoms often go away after a few months of being on the pill, but the feelings don’t subside, go back to your health-care provider and ask for her advice. If you’re having bad cramps during your period, you might decide you’re a good candidate for extended-use pills. Or, it might be as simple as switching formulations. There are dozens of brands of the pill on the market with names like Yaz, Sayfral, Amethyst, Kelnor, and Natazia. They contain different active ingredients in different formulations. Your health care-provider probably prescribed you her favorite or chose one that she thought matched your needs, but if it’s not the right one, you and she can try another. Keep in mind that insurance coverage may play a role in the brand of pills that you can try—at least without paying too much out of pocket—as most pharmacy plans have different fee schedules for different brands, and you may not be able to switch without a hefty co-pay.

Other hormonal birth control methods—such as the shot or the implant—have similar side effects, but offer less room for trial and error, because there are fewer brand offerings and you can’t simply stop taking them. The shot lasts three months whether you like the side effects or not. The implant is designed to last four years and there is only one on the market (Nexplanon), but it can be removed early for any reason. Again, talk to your provider about any side effects you are experiencing and work together to decide if you should give it a few more months to adjust or if it’s time to decide on another method entirely.

The same can be said about IUDs. There are more devices on the market than there have been since the 1970s—a few hormonal versions and one that uses copper—but once they are in place, there is not much you can do to mitigate the side effects.

However, side effects of the IUD are often minimal. Most women will experience some pain during the insertion process, and some cramping or back pain for a few days afterward. Pain medications such as ibuprofen can help with these, as can simple things such as getting under the covers and turning on a heating pad. Once it’s inserted, side effects of the IUD include irregular periods and spotting between periods. Hormonal IUDs can cause some of the same side effects as the pill or implant, such as mood changes or headaches. And the copper IUD can cause heavy bleeding. Often these symptoms go away on their own once your uterus has gotten used to its new roommate. If this doesn’t happen after three or four months, however, it’s worth talking to your health-care provider and considering a different method.

And sometimes, it takes a few tries. As an example, let’s flash back to 1992. I had just started taking the birth control pill as a cure for horribly heavy and painful periods. I was an emotional wreck. I called my mother from my dorm room screaming and crying. Toward the end of the conversation, she gently questioned whether the pill might account for some of my distress. “Of course not,” I said, and slammed down the phone.

A month later, when I went for a follow-up appointment at the university health center. I told the nurse practitioner that I was kind of unhappy. “I think I hate my life,” I said, “but it could be the pill.” She replied, “Well, the pill is certainly easier to fix.” She put me on a multiphasic pill, which started with a low dose and got a little stronger each week. Each week’s pills were a different color; I came to understand that peach-pill weeks would be my moodiest. A few years later, I switched back to a monophasic pill that had a different formulation, and my moodiness went away. I stayed on it for decades, though along the way I tried the extended-use pills and progestin-only ones, but each time I eventually switched back to my favorite, low side-effect brand.

In fact, my decision to move to an IUD also ends with me switching back to my favorite birth control pills after a few months. After a couple of successful decades on the pill with some breaks for pregnancy, my gynecologist suggested that I finish out my reproductive years with an IUD. (Actually two IUDs, because the hormonal Mirena lasts for 5 years, and I’m only 43.) As a sexuality educator, I’m highly in favor of IUDs because they are safe and very effective—by removing the possibility of user error, they are more than 99 percent effective at preventing pregnancy. But as a patient, I just didn’t like mine. I woke up each morning with pain in my lower back and felt like I had mild menstrual cramps all day, every day. Following my own advice, I waited a few months for the symptoms to settle down, but they didn’t. After six months, I decided I had to listen to what my body was telling me and I had the device removed. I’ve been happily back on the pill for six months now.

There are some side effects of all hormonal methods that should not be tolerated, even for a few weeks or months, because they could signal a serious health issue such as a blood clot. For the pill and other hormonal methods look out for a new lump in your breast, a sudden very bad headache, achiness in your legs, pain in your abdomen or chest, interrupted vision (like seeing bright flashes or squiggly lines), yellowing of the skin, or difficulty breathing. Women who have gotten an IUD inserted should also look out for difficulty breathing along with chills, fever, soreness in the lower abdomen, intense cramps, heavy vaginal bleeding, and pain during intercourse. Rarely, IUDs can come out of the uterus on their own. In such a case, you might feel the string on the IUD hanging lower in your vagina or feel hard plastic poking through your cervix. If you experience any of these symptoms, seek medical attention right away.

More Research Will Bring More Choice

Though we take it for granted now, the birth control pill was a game-changer for women. By allowing women to take control of their fertility and family planning, the pill helped women limit family size and usher us into the workforce. Those women who took the early iterations of the pill suffered unnecessary discomfort because scientists did not know that lower doses would be effective without the side effects.

Today, we know. And we have choices. Not only did that first pill, marketed as Enovid, pave the way for the hundreds of formulations and brand names to follow, it also tested the concept of preventing ovulation, which is behind other hormonal methods including the shot, patch, ring, and implant. Similar research into IUDs has ensured that women now have a number of safe and effective options. Researchers should continue to look for new methods or improvements to existing methods that can reduce the side effects women experience even further.

It is time for men to get some choices in birth control as well. Scientists have many ideas of what this might look like, and though none will be hitting the pharmacy shelves very soon, we should encourage continuing research. It can be entertaining to make fun of the idea of men being unable to handle any little bit of discomfort, but we should probably put the kidding aside and encourage these researchers to be vigilant in their quest for a male method that is safe, effective, and has few side effects. More research will equal more choices, and more choices are better for everyone.

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