Conversations with Women About Female Sexual Dysfunction (FSD)
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235 Conversations With Women About Female Sexual Dysfunction (FSD) and Treatment With Bremelanotide Presented at the 22nd Annual Fall Scientific Meeting of 1 2 3 4 5 5 6 Sexual Medicine Society of North America Patricia E. Koochaki , Stanley Althof , Sheryl A. Kingsberg , Michael A. Perelman , Johna Lucas , Robert Jordan , Dennis A. Revicki November 3– 6, 2016 Scottsdale, AZ 1PEK Market Research, Inc., Cincinnati, OH, USA; 2Case Western Reserve University School of Medicine, Cleveland, OH, USA; 3University Hospitals Case Medical Center, Cleveland, OH, USA; 4Weill Cornell Medical College, New York, NY, USA; 5Palatin Technologies, Cranbury, NJ, USA; Evidera, Bethesda, MD, USA • Recognizing There Was a Problem Partner and Relationship Effects Physical Effects of BMT Sexual Satisfaction Increased Summary of Benefits That Women With HSDD With/Without Introduction Results Decreased Arousal During the interviews, women described how they Partner Blamed Himself • About three-quarters of all participants reported experiencing Approximately two-thirds of participants taking 1.25 and 1.75 mg Female sexual dysfunctions (FSD) include a Pre-Study: Conceptualizing and Explaining Why began to recognize they were experiencing sexual “There were a couple of times where he did blame himself. He physical effects from BMT of BMT reported an improvement in sexual satisfaction. range of distressing, multifactorial conditions, They Experienced FSD difficulties that required intervention. thought something was wrong with him.” • Nine of 10 women taking the 1.75-mg dose of BMT reported “A positive way …I think it restored or rebuilt what [sexual such as dysfunctions of sexual interest/desire, • Most women were unaware that FSD is a recognized “Because for a young man our age, he’s thinking like, it must be me. a positive physical effect Increased sexual arousal, a delay in or absence of orgasm, medical condition “At first it was gradual, but then, all of a sudden, it You don’t like me. And he was putting a lot of pressure on himself .” • Tingling in the genital area and sometimes in other parts of satisfaction] we had before, that had kind of been lost .” sexual desire and sexual pain .1,2 The most common sexual • None used the phrase “sexual dysfunction” to describe was like, you know we went from having sex once Partner Emotionally Impacted the body, as well as a transient feeling of warmth or flushing, “Greatly [impacted sexual satisfaction]. Things were better. a week to not even having it once a month.…and, I actually wanted to have sex more often .” Increased concern expressed by women is diminished or their problem “He actually went through a phase for a couple of months where were the most frequently mentioned physical effects sexual 3,4 I thought maybe was him. Is he not wanting to? lack of desire for sexual activity, which may he seemed almost depressed .” “Of course [sexual satisfaction increased]! You didn’t get Improved Improvement satisfaction • Responses concerning the cause of their condition “I actually felt, kind of like, a tingling sensation, if you will, Increased be diagnosed as hypoactive sexual desire But it wasn’t him. It was me .” that from everything I’ve been saying? …Every single time. ability to in sexual varie d— having/taking care of children was mentioned Creates Stressful Barriers, Magnifying Other Problems in my clitoral region .” sexual “It’s just there would be times when it was…when it achieve function and Improved disorder (HSDD), if the lack of desire causes most frequently, followed by aging Every time it was like the first time .” arousal just happened, whether it was him or me. I guess “…that wall of frustration between my husband and I as far as lack “You don’t really perspire, it’s just a warm feeling all over.” orgasm responsiveness mood, sexual Improved distress. Bremelanotide (BMT), a novel cyclic of sexual interaction that we had. When you are stressed about the “Much more confidence that I was satisfying him more, self-image, partner 7-amino acid melanocortin-receptor agonist Women’s Thoughts on Why They Experienced FSD there was a time when I would initiate it...There was sexual part, everything else seems to get bothered more easily .” “I would get a tingling down in the genital area. (Interviewer: and I was satisfying myself .” and relationship with the potential to modulate neural pathways a time when it was both of us initiating it and then And was it a pleasant thing?). Yes, it was pleasant. That con!dence “After the birth of my third child, I noticed a very rapid him initiating it, and, then to a point where I am Creates Uncertainty, Distrust, and Concerns About Viability Improved Self-Confidence and Sexual Self-Image Improved involved in sexual response ,5,6 is being would last for a good hour or so .” decline in sexual drive…It was pretty severe, enough to like, No!” of Relationship lubrication developed to treat FSD. send me to a doctor to beg for help .” “You worry about, well, if you’re not getting it with me, are you Sexual Desire Increased A majority of women taking the 1.25- or 1.75-mg doses of BMT reported experiencing an improvement in self-confidence “I really honestly think it was, that it is, because I’m Multiple Aspects of Women’s Lives Were going somewhere else? You have all of those kinds of con - Approximately 6 of 10 women receiving 1.25 or 1.75 mg of cerns.”“I know in certain arguments that we might have he will or sexual self-image. getting older.” A ffected by FSD BMT reported experiencing an increase in sexual desire. Aims “At first I thought maybe hormones; I think it is hormonal .” say that he thinks my eyes are wandering.” “I feel more confident now. Before, you sort of feel inade - The objectives of these interviews were to “I could have been (in) early menopause .” Impacts on Her “[Before] I really didn’t want to. Please, not tonight. But you Sexual Satisfaction—What Women Want and take it, and you want t o… I started to look forward to it again .” quate. What’s wrong with me? …I don’t have that problem Conclusions understand the impact of FSD and to provide “…some of it I think is just my physica l… my weight gain. Absence of Physical and Mental Responses to What Was Missing anymore .” a contextualized understanding of the effects …I honestly put on 20 lbs in 4 years. I have more of a Her Partner “I feel it made me want to again. It did sort of restore things • These interviews provided a wealth of contextual Mutual Feeling of Sharing Intimacy, Giving back to our original state .” “I felt sexy. I had control of my body. I felt satisfied and felt of BMT and the meaningfulness of the benefits desk job now, so I’m not moving around. And, I think that Sexual Desire* “I didn’t have the feeling, and then, the sexy. Felt frisky.” understanding of women’s experiences with FSD and it provides, beyond the previously reported may have something to do with it, because just putting on lack of desire altogether. So my body just and Taking “I was initiating more about 50% of the time. Pre-trial it was weight, and being tire d…” “I definitely felt better about myself. I felt like my sexual life was the positive impact that successful treatment with quantitative clinical study results. doesn’t respond very well when I am in “It’s more of a feeling. I guess I want to say a mutual feeling 70% him initiating .” that situation.” finally in step with the rest of my life, or it was getting there .” “I have no desire at all. I could go for the next 6 months between the two of us as to be giving each other the Sexual Arousal Increased BMT had on their health and well-being without it and it would not faze me. And, that right there, Arousal † “When he would caress me or try to pleasure of having that intimacy, that physical closeness, “I think it just made me feel desirable, sexy, younger .… Methods to me, scares me. I don’t understand that. I have no stimulate me, it wouldn’t happen. Not just that arousal, everything .” BMT had a positive effect on sexual arousal, particularly at and, in my mind, ‘oh, if I feel this good, maybe I look as • The effects of FSD extend well beyond physical understanding of that concept to me because it’s never mentally, but physically as well.” the 1.25- and 1.75-mg doses, where approximately two-thirds good as at 21 .’” symptoms • In a blinded phase 2b trial, premenopausal happened before, not even for a little while.” It’s Not Just About Sex of women said they experienced an improvement. women with HSDD (with or without female Orgasm “Most of the time, I was faking [orgasms]… Improved Mood “I thought it was a mind thing.” because I wanted him to be happy.” “I mean, intimacy, the physical satisfactio n— all of it is • Most participants reported improvements in their sexual arousal disorder [FSAD]) self-injected “[Before the trial], it was hard to get aroused. And when Approximately half to two-thirds of women taking the 1.25- or Physical Changes That Made Having Sex Uncomfortable important. The intimacy is most important because, without I did, I would get so close to the orgasm and then it was sexual response, frequency, quality of sexual placebo or 1 of 3 doses of BMT (0.75, 1.25, 1.75-mg doses of BMT reported feeling happier, relieved, Physician Interactions for Women it, it’s just sex .” gone, and you would spend so much time trying.