Men have Pills for their Sexual Dysfunction, Why Can’t Women?

A Response to “How Addyi, the ‘Female Viagra,’ Can Do More Harm Than Good” By Dr. James A Simon

Earlier this month, Dr. Janet Brito, a sex therapist based in Hawaii, raising a few questions about the efficacy and wisdom in using Addyi, known as the “Female Viagra,” to treat sexual dysfunction in women. The article she wrote has been removed from that site that posted it due to the inaccuracy of the information the article contained. In spite of this, I felt that it was important to address her concerns, and to explain how Addyi is, in fact, an empowering tool that women who are suffering from hypoactive sexual desire (HSDD) or female sexual interest/arousal disorder (FSAD).

Efficacy and Use

Regarding the efficacy and use of Addyi, Dr. Brito makes several claims that are either blatantly false or not based in fact. She states that Addyi “needs to be taken every day for at least 8 to 16 weeks before it starts working.” According to the package insert itself (approved by the FDA), if Addyi isn’t working by 8 weeks, its use should be discontinued.

Brito brings up the fact that “according to the Addyi website, ‘it’s exact mechanism of action is not fully understood,’” without any other comment, perhaps implying that this is a reason it should not be used, but this fact is also true for all antidepressants, pain killers, appetite altering medications and most medicines generally.

“Initially, flibanserin was slated for the treatment of depression. After two rejections by the FDA, Addyi was approved in 2015 to treat low sexual desire in premenopausal women — despite trials showing only minimal results compared to a placebo,” states Dr. Brito. Addyi was originally developed to treat depression, but in people with major depressive disorder where Addyi didn’t work for depression, it increased sexual desire. That’s correct, it worked to increase sexual desire even in women that were clinically depressed.

Thus, the company behind Addyi pursued sexual dysfunction as an option to help women suffering from hypoactive sexual desire disorder or HSDD or female sexual arousal disorder or FSAD. The drug was rejected twice by the FDA, in my opinion, because the FDA kept changing their mind about what they wanted.

The company was trying to develop a first-in-class medication where the tools for assessing efficacy weren’t invented yet. For responders to the medication (excluding all the non-responders), they had 5.7 sexual events per month, which can’t be considered minimal, and which the responders themselves judged as a meaningful improvement.

“Their desire stats did change and show an increase when researchers measured it according to the Female Sexual Function Index — but if participants didn’t notice their own response, can it really be considered effective?” asks Dr. Brito. The Female Sexual Function Index is a validated questionare answered by the study participants, an approach agreed upon with the FDA. Participants reply to the FSFI based on how they, the participants, feel.

Social Oppression and Relationships

Dr. Brito spends a great deal of the article drawing a connection between a pill to treat sexual dysfunction for women and a long history of societal oppression of women. I fail to see the connection, as Addyi is only prescribed to patients who wanted to increase their sexual desire for one reason or another, not because their partners or society had problems with their libidos as Brito suggests.

Brito’s other accusation that those who prescribe Addyi are not taking into account any of the other factors that might contribute to low sexual desire, is not based in fact. Study participants were excluded from entering the research studies if they had any other reason for their loss of sexual desire, any reason. Such reasons would have included: depression or other medical conditions, medications known to affect sexual function, and any relationship problems, just for examples. Erectile Dysfunction has many causes and factors, and yet men are prescribed Viagra without a second thought. Shouldn’t women have equal access to a pill that can help them with their sexual function, too?

Like those who are prescribed a pill for depression, Addyi can help women start living their lives again, and get back to their old selves.

Brito also writes, “…sometimes the issue is about the relationship you have with yourself, not others.” On this point, I totally agree. But women with relationship problems with themselves or their partners were excluded from the clinical development of Addyi as noted above. Addyi is there for women who have been diagnosed with HSDD or FSAD, who are in a healthy relationship with their partners, and who want to get back to enjoying their partners sexually.

Dr. Brito concludes the article with this line, “Instead, ask yourself, honestly, if any of the aforementioned factors are impacting your life. And, if so, what lifestyle changes to embark on to start to feel better on your terms.” Addyi, Viagra, anti-depressants, and a slew of other medications may not be the best choice for every patient, but the patient does have a choice.

Why a sex therapist (who cannot even prescribe Addyi or medication generally) is ruling out a drug that is effective, readily available, and which delivers on the promise to increase “sexual desire and satisfying sexual events,” is beyond me.

To discuss if Addyi might help you or determine if you might be suffering from HSDD or FSAD, give us a call at 202.293.1000 or e-mail us to make an appointment at our office in Washington, D.C.

Dr. Rachel Rubin
Dr. Rachel Rubin

Until recently, I never knew sexual medicine was its own specialty. I mean, of course there has to be a field of sexual medicine, since there are medical fields for every other aspect of biological human life, but when I first heard about IntimMedicine Specialists, I had lots of questions. What does a sexual medicine specialist do? What can they offer that a general physician can’t? What could I expect at an appointment, and what would I make an appointment for?

I got to sit down with Dr. Rachel Rubin, an expert in sexual medicine and urologist on staff at IntimMedicine, and ask her some of these questions. She put me at ease right away, asking me about myself with genuine interest before we got to the questions I had for her. I hope you’ll find her answers as enlightening as I did!

Dr. Rubin trained as a urologist at Georgetown University Hospital. Early on she realized that talking about sexual issues was very uncomfortable for patients and even more uncomfortable for the doctors who were trying to train her. “Research has shown that medical professionals don’t do a very good job of bringing sexual issues up with their patients, often because they feel there is a lack of time and expertise to be able to follow up on the questions they get asked,” she said. Dr. Rubin found that she was not afraid to ask people questions about sexual issues, and her interest in treating sexual dysfunction only grew. She completed a sexual medicine fellowship in San Diego and then joined the team at IntimMedicine.

“Sexual medicine is a relatively unknown field made up of many different types of providers who believe strongly in quality of life and improving the sexual health of their patients and their partners,” said Dr. Rubin. “We see people with erectile dysfunction, low libido, penile curvature, pelvic pain, urinary incontinence, and hormone issues, among other things.”

Many times, Dr. Rubin said, patients and their doctors are not only uncomfortable discussing sexual health—they also don’t have time in a 15-minute visit to address such intimate issues. “We don’t see 50 patients a day. We spend a lot of time with our patients, and I pride myself on being able to work within the medical community to build a multidisciplinary team to help each individual patient and couple. Sometimes there needs to be medical treatments or surgeries, and sometimes we need specialized physical therapists to be involved. We often team up with mental health professionals as well, because no one ever taught us how to talk about sex and getting a ‘coach’ to help with that is extremely important. Sexual medicine is very much a ‘team sport’ in terms of figuring out which team members need to be involved with each individual case – it’s not a one-size-fits-all model.”

Another member of that team? The patient’s partner. Dr. Rubin encourages patients who feel comfortable doing so to bring their partners to appointments.

“It is not uncommon that I see a patient and then their significant other comes to see me later, realizing it ‘takes two to tango,’” she said. “Oftentimes you have to think of each patient in the context of a couple, and it’s important to help both people.”

Maybe you have something that is bothering you about your sexual health, but you’ve got too much else going on or you’d rather not think about it, and definitely not talk about it. I asked Dr. Rubin what she would say to people who keep putting off seeing a sexual medicine specialist. “Quality of life is incredibly important,” she said. “Focusing on yourself and your health as a couple is valuable.” Dr. Rubin went on to emphasize that sexual health is closely connected to general health. She also added that “focusing on your sexual health may actually benefit many other parts of your life.” For example, “Erectile dysfunction can be a sign of early cardiovascular disease.”

“Before I see a new patient, I always have a screening phone call with them first, just to make sure it’s a good fit for them before they make an appointment,” Dr. Rubin told me when I asked her what people could expect from an appointment with her. “When people come into my office, they sit across from me, fully clothed, and we just have a conversation. I spend a lot of time showing them anatomical diagrams and explaining everything we’re going to do before we ever do an exam or procedure. Nothing invasive ever happens without a full discussion and without the opportunity for lots of questions to be asked.”

Dr. Rubin’s tone became both more impassioned and gentler when I asked her to name one thing she wished people understood about sexual dysfunction. It was clear to me that she cared deeply about this when she answered. “People are often afraid to admit that they have a problem, because they’re so afraid that it means there is something different or abnormal about them. I understand that it can provoke a lot of anxiety to just come out and say ‘I have a problem, and it’s sexual,’ even to a doctor. Nobody taught any of us how to talk about sex to our partners, or to our doctors, so it can feel very isolating, but the truth is all of these issues are so incredibly common. After speaking with me, my patients are very comforted in knowing that they’re not alone and that there is help.”

As we ended our chat, Dr. Rubin said, “This is all we do,” referring to the team at IntimMedicine Specialists. “Our patients have access to all of the expertise we represent and receive very individualized care. We’ll take the time to get to know you and help you focus on your sexual health.”

So now, I have a question for you: why are you waiting to start working on your sexual health?

 

Call 202.293.1000 to make an appointment with IntimMedicine Specialists in Washington, D.C.

Also: follow Dr. Rubin on twitter @rachelsrubin1 and the IntimMedicine team @intimmedicine

I’m pleased to share with you some exciting news about a treatment for low sexual desire that has an unintended consequence you may actually appreciate–weight loss. Some patients reported that after using flibanserin for as short as 8 weeks, that they began noticing that their clothes were looser and the number on the scale was surprisingly lower. Sounds too good to be true, I know, but let’s take a look at what flibanserin is and how it affects the brain.  Flibanserin is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, which influences biological and neurological processes. While its primary effect is to increase sexual desire, it also has an impact on anxiety, appetite, memory, mood, and sleep. Researchers found that this treatment reaches the part of the brain that experiences sexual desire, but it may also impact satiety, that feeling of fullness at the end of a meal. Unlike some weight loss medications, there appears to be no weight regain with flibanserin (at least for about 18 months of study). More research will help us learn more about these effects, both sexual desire and weight, over the long term, but this is considered clinically meaningful in my book.

Flibanserin was first approved by the Federal Drug Administration (FDA) in August 2015 for low libido in women and was immediately dubbed the “female Viagra” although that is a misnomer.  Viagra treats a blood-flow issue to the penis, a physical issue, not desire which is an issue of the mind. For most women, sexual desire starts “north,” in the brain.

The Science Behind Improving Sexual Desire
Flibanserin was originally created as an antidepressant and although it didn’t work very well for depression, patients noted a pleasant side effect, an increase in sexual desire. It went back to the lab for further research, leading us to this moment in a new sexual revolution for premenopausal women. Considering that many women experience sexual dysfunction at some point, it is worth going for an evaluation with your doctor, ruling out extenuating circumstances (i.e., relationship problems), and see if this loss of desire is an actual diagnosable disorder, hypoactive sexual desire disorder or HSDD. If it is there is a solution.

Optimal Timing and Dose
The effectiveness of the 100 mg bedtime dose of flibanserin was evaluated in three pivotal 24-week trials of 2,400 premenopausal women with hypoactive sexual desire disorder (HSDD), otherwise known as “not ever in the mood for sex…ever!” The average age of women in the trials was 36 years, and these women had experienced diminished sex drive for about five years. While many have said that this medication only works in a small percentage of patients, and only has a little benefit at that, our experience is that those who respond do so in 8 weeks, and really recognize the difference. However, flibanserin has not been shown to enhance sexual performance in normal women, but it’s a starting point for women who have not been able to put a name to their low sexual desire condition, or have not found an effective treatment.  Additional treatments such as vaginal estrogen and or testosterone may be used for physical issues such as vaginal dryness or pain with intercourse.

Flibanserin is not without some side effects such as dizziness and in a few cases, lower blood pressure. But taken as directed, specifically, at bedtime, and without alcohol, you may be in for a satisfying sexual experience and some weight loss, which you will be thankful for all year long.

glansNo, this post isn’t about penises or vibrators. (Why do our minds always go there!) I’ll reserve that subject for Part 2. This is about the clitoris. Yes, the clitoris, “a small erectile female organ located within the anterior junction of the labia minora that develops from the same embryonic mass of tissue as the penis and is responsive to sexual stimulation” (according to Merriam-Webster on-line dictionary). While seldom the subject of much scientific research, a recent publication* investigated the relationship between clitoral size and sexual function (including the extensive internal portion – “out of sight, out of mind” you might say).

In a small convenience sample of women having a pelvic MRI for other reasons (such as fibroid tumors), these researchers compared clitoral size and each woman’s sexual function as measured by several validated scales. Paradoxically, women with the smallest clitorises (yes, that’s the correct pleural of clitoris), specifically the clitoral body and crus (see diagram below), had the best sexual function. Those women with a smaller clitoris tended to have better desire, arousal, lubrication, and orgasm. The authors of the study suggest that a greater density of nerves, basically squeezing the same number of nerves into a smaller space, is what leads to better function.

There are several limitations to this study, so take these findings with a grain of salt. The relatively few women who participated were having their MRIs done for other medical reasons besides participation in this sexual function study. Therefore, the findings may not actually be generalizable to all women, especially “normal” women without another existing medical condition. But, this study does give a whole new potential meaning to the oft-quoted “good things come in small packages” idea.  And that’s c.o.m.e., not c.u.m! Really, does your mind always go there?

Interested in women’s sexual health? Contact us for an appointment.

 

* Vaccaro CM, Fellner AN, Pauls RN. Female sexual function and the clitoral complex using pelvic MRI assessment. European Journal of Obstetrics & Gynecology and Reproductive Biology 180: 180–185, 2014.

 

The “Pink Pill”-Who Is It For?

Pink PillsThe “pink pill”, flibanserin, was developed for premenopausal women. Although preliminary data on flibanserin use among postmenopausal women are available, the drug was studied primarily in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), the indication sought at this time.

In the premenopausal population, problems such as pain with intercourse or hyperestrogenism aren’t typically present, simplifying the identification of HSDD. In clinical trials of the drug, HSDD was secondary, generalized, and acquired—that is, it followed a period of normal sexual function. And it didn’t come and go but was present regardless of location and circumstance.

Study participants had had a normal sex drive before their desire “turned off,” an occurrence they found distressing.

Clinicians, myself included, have been frustrated by our inability to prescribe an effective treatment for this common problem. The recent recommendation of an FDA Advisory panel to approve flibanserin for the treatment off HSDD in premenopausal women brings us a step closer to having additional options for treatment.
(Excerpted from an editorial by Dr. James Simon published in OBG Management, July 2015)

 

Interested in women’s sexual health? Contact us for an appointment.

Hypoactive Sexual Desire Disorder (HSDD) is described as having the following characteristics:

  • persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activitypillows-820149_640
  • marked distress or interpersonal difficulty in response to this deficiency
  • lack of another explanation known to affect sexual function.

In other words, a person once had a healthy desire for sex which they have lost, and there is no other explanation for that loss of interest or desire. In addition, the loss of this desire is noted by the person and the change is causing distress, relationship difficulty or both. (Source: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)

In clinical practice, HSDD is easily identified using the Decreased Sexual Desire Screener (DSDS), a simple screening test that asks 4 yes/no questions:

  1. In the past, was your level of sexual desire or interest good and satisfying to you?
  2.  Has there been a decrease in your level of sexual desire or interest?
  3.  Are you bothered by your decreased level of sexual desire or interest?
  4. Would you like your level of sexual desire or interest to increase?

A “yes” response to each of these questions is required. In addition, a fifth question asks whether a number of conditions, drugs, or circumstances might be responsible for the decreased desire or interest:

  • an operation, depression, injuries, or other medical condition
  • medications, drugs, or alcohol you are currently taking
  • pregnancy, recent childbirth, or menopausal symptoms
  • other sexual issues you may be having (pain, decreased arousal or orgasm)
  • your partner’s sexual problems
  • dissatisfaction with your relationship or partner
  • stress or fatigue.

Only when all of these items are excluded as possibilities can a diagnosis of HSDD be made. (Source: OBG Management, July 2015, sidebar)

 

Interested in women’s sexual health? Contact us for an appointment.

Studying the chemistry behind romantic relationships can seem to take the fun out of things – but it does give researchers a better idea of what causes the powerful emotions that poets have written about for years. It turns out there are several chemicals in the brain and bloodstream that play key roles in either the lust, attraction or emotional attachment phases of a love relationship. In the initial lust phase, these three substances can combine to create a highly addictive scenario:
Continue reading “Couples’ Cocktail – The Chemistry of Attraction”

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