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Home » Drug Information » New Medical Therapies™

Sexual Dysfunction

November 17, 2014

Pfizer reported results of a phase IV study of Pristiq Extended Release Tablets 50mg and 100mg doses v. placebo focused on sexual function in adult patients diagnosed with major depressive disorder (MDD). In the phase IV, multi-center, randomized, double-blind placebo-controlled study, a total of 924 patients, 18-years or older, with a baseline HAM-D17 score of ≥20, were randomly assigned to Pristiq 50mg/day, Pristiq 100 mg/ day or placebo in a 1:1:1 ratio over an eight-week period. The primary efficacy end point for the study was the change from baseline in HAM-D17 total score at week eight. Incidence of sexual dysfunction was assessed using the ASEX data. In adult outpatients with MDD with baseline sexual activity and at least one post-baseline assessment, effects on ASEX total and item scores were comparable for the Pristiq 50mg and Pristiq 100mg groups and placebo. Rates of sexual dysfunction were comparable between each Pristiq dose and placebo at baseline (placebo, 52%; Pristiq 50mg/d, 56%; Pristiq 100mg/d, 54%) and at week eight (placebo, 45%; Pristiq 50mg/d, 49%; Pristiq 100mg/d, 47%).

March 17, 2014

Palatin Technologies issued results of a phase IIb trial of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD), both forms of female sexual dysfunction (FSD). Approximately 400 premenopausal women diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both were enrolled in the multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial. Patients were treated for 16 weeks and randomized to one of four double-blind treatment groups receiving placebo or subcutaneous (SC) bremelanotide doses of 0.75mg, 1.25mg or 1.75mg. Responder analyses showed bremelanotide had a statistically significant increase in the percentage of women whose total score on the Female Sexual Function Index (FSFI) improved: 69% for 1.75mg v. 46% for placebo (p<0.05). A significantly higher percentage of women on bremelanotide v. placebo achieved at least one satisfying sexual event (SSE): 55% for 1.75mg v. 37% for placebo (p<0.05). As-needed administration of bremelanotide 1.75mg v. placebo also demonstrated episodic increases in levels of desire (0.4 v. 0.0, respectively) and in the women’s satisfaction with their levels of desire (0.6 v. 0.1, respectively). Palatin anticipates commencing enrolling patients in phase III clinical trials in the second half of this year.

November 19, 2012

Palatin Technologies issued results from a phase IIb trial of bremelanotide for the treatment of female sexual dysfunction (FSD). This multi-center, randomized, placebo-controlled, parallel-group dose-ranging study enrolled 400 premenopausal female patients with female sexual arousal disorder, hypoactive sexual desire disorder or both. Subjects received subcutaneous doses of bremelanotide 0.75mg, 1.25mg or 1.75mg, or placebo, for 16 weeks. Data demonstrated that patients receiving bremelanotide showed statistically significant improvement (p=0.018) in the number of Satisfying Sexual Events (SSEs), with a mean change from 1.6 at baseline increasing to 2.4, versus placebo which had a mean change from 1.7 at baseline to 1.9. Over the study period, bremelanotide-treated patients saw a 50% increase in SSEs versus a 12% increase with placebo. Bremelanotide was well tolerated. The most frequent adverse events were facial flushing, nausea and emesis. Based on these data, Palatin Technologies are anticipate phase III activities will begin in the second half of 2013.

October 22, 2007

Palatin issued positive results from a phase II trial of bremelanotide for the treatment of female sexual arousal disorder. This double-blinded, placebo-controlled trial enrolled 163 pre- and postmenopausal women. The subjects were followed for one month to determine their baseline level of sexual dysfunction and were then randomized to receive intranasal doses of either placebo or bremelanotide (10 mg). The subjects were assessed over a two month period for changes in sexual function using the Female Sexual Encounter Profile (FSEP), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Score (FSDS). The postmenopausal women showed statistically significant improvements in the endpoints when compared to baseline and placebo, and overall satisfaction at one and two months. The pre-menopausal women treated with bremelanotide showed statistically significant improvements in the endpoints when compared to baseline and overall satisfaction at one and two months. However, while a positive trend toward improvement was seen in this group when compared to placebo, the differences were not statistically significant. Based on the results, Palatin plans to move forward with the development of bremelanotide.

March 5, 2007

Palatin and King Pharmaceuticals announced positive results from part two of a phase IIa trial of bremelanotide in the treatment of female sexual arousal disorder (FSAD). This double-blind, randomized, placebo-controlled, single dose, cross-over trial enrolled 27 post-menopausal women who received a 20 mg dose (2 x 10 mg) of intranasal bremelanotide or placebo. Subjects were monitored for three hours then asked to complete a Treatment Satisfaction Index questionnaire at 24-hours post-dose. Treatment was found to be safe and well tolerated with the most commonly reported adverse events including nausea, headache and nasal congestion. Efficacy results revealed that 73% of the women on bremelanotide reported an increased level of genital arousal compared to 23% of women on placebo. Also, 46% of the treated women reported an increased level of sexual desire while only 19% responded similarly after placebo treatment. Phase IIb trials of bremelanotide in this indication are ongoing.

May 30, 2005

NexMed issued positive results of a clinical trial of Femprox (alprostadil), for the treatment of female sexual arousal disorder (FSAD), at the Annual Meeting of the American Urological Association. The drug yielded significant efficacy in the primary endpoint, improvement in rate of arousal achievement on the Female Sexual Encounter Profile (FSEP) diagnostic scale, at two evaluation periods. Specifically, 38.7% of patients using the drug met the criteria after the first evaluation period, vs. 17.1% for placebo (p<0.001), and 51.5% achieved success after the second, vs. 28.6% for placebo (p<0.001). Positive efficacy trends were also noted in secondary endpoints, including Female Sexual Function Index (FSFI), other FSEP responses, Female Sexual Distress Scale (FSDS), and the Global Assessment Question (GAQ). This multi-center randomized, double-blind, placebo-controlled study enrolled 400 FSAD patients in China, who received one of three doses of the drug or placebo up to 10 times during two treatment periods, prior to sexual activity.

February 14, 2005

Palatin Technologies and King Pharmaceuticals have announced positive results from a phase II a pilot study of their investigational drug PT-141, for the treatment of female sexual dysfunction in pre-menopausal women. Data from the study met their primary efficacy endpoints, with a significantly greater portion of patients reporting increases in their levels of sexual desire and genital arousal, vs. placebo (p<0.05); additional analysis showed statistical correlation between the incidences of the endpoints. The most common adverse events associated with treatment included nausea, headache and nasal congestion. This double-blind, randomized, placebo-controlled, single-dose, cross-over study enrolled 18 pre-menopausal women with FSD at a single site in New York. Subjects received a single administration of two 10 mg intranasal administrations of either PT-141 or placebo, with 3 hour follow-up observation and 24 hour Treatment Satisfaction Index assessment. The companies announced that they found the results of this trial sufficient to warrant further development of the drug for this indication.

November 22, 2004

Auxilium Pharmaceuticals reported positive results of a clinical trial of their approved testosterone replacement gel Testim in hypogonadal HIV-positive men. Top-line results indicate that the drug was efficacious in treating symptoms of hypogonadism, with significant improvements observed in reported sex drive, erectile function, and sexual-satisfaction with sex life, as well as satisfaction with androgen therapy. These improvements in sexual function resulted in a significantly fewer Testim treated men requiring titration to a higher dose compared to men treated with AndroGel, another approved topical testosterone therapy (30% vs. 74%; p<0.05). This approved-therapy controlled study enrolled a total of 48 HIV-positive hypogonadal men who had not achieved adequate symptom relief on AndroGel.

September 13, 2004

Cellegy Pharmaceuticals reported second interim analysis from a phase II trial investigating Tostrelle (testosterone gel) .5% for the treatment of sexual dysfunction in low-testosterone postmenopausal women. Results demonstrated the gel produced testosterone levels that were within the normal range of young women (p<0.001) and produced a 65% improvement in the number of satisfying sexual events, a 30% increase over placebo. The randomized, placebo-controlled study enrolled 103 postmenopausal women with low testosterone levels who were distressed by symptoms of sexual dysfunction. The study was designed to determine testosterone blood levels and the efficacy of topical gel administered daily. Full results will be reported at the International Society for the Study of Women's Sexual Health (ISSWSH) during their annual meeting in Atlanta on October 28-31, 2004. The company has now begun preparations for phase III trials.

Novo Nordisk has announced positive results of a phase II study of liraglutide, the company’s GLP-1analog, for the treatment of type 2 diabetes. The study found that liraglutide was significantly efficacious in promoting glycemic control and weight loss, especially in combination with metformin. Further, the combination of metformin and liraglutide produced significantly better glycemic control and weight loss than the combination of metformin and glimepiride (an approved therapy), and was the only study regimen to reduce HbA1c levels by greater than 1%. The randomized, double-blind study enrolled a total of 144 subjects with type 2 diabetes. Novo Nordisk announced plans to initiate phase III trials by the end of 2004, based upon these results.

July 19, 2004

Vivus announced the data from their phase II study of Alista (alprostadil), their topical gel for the treatment of Female Sexual Arousal Disorder (FSAD). Analysis showed that the drug achieved significant improvement over placebo in alleviating both primary and secondary symptoms associated with FSAD: Alista users experienced significant increases in the number of satisfying sexual encounters and the level of sexual arousal, a decrease in distress, and a significant portion of Alista doses resulted in satisfying sexual events, compared with placebo. The double blind, placebo controlled crossover trial enrolled 36 pre-menopausal women across 6 sites, who received Alista or placebo on an outpatient basis. Vivus plans to use these results to support development of Alista for pre-menopausal FSAD.

November 17, 2003

BioSante Pharmaceuticals reported positive interim results from an ongoing phase II trial investigating LibiGel, a topical testosterone for the treatment of female sexual dysfunction. Results showed that after three months of treatment, subjects demonstrated 130% increase from baseline in the frequency of satisfying sexual events, as measured by patient diaries. Data indicated an effective LibiGel dose and that treatment was well tolerated. The double-blind, placebo-controlled study was designed to determine the effect of LibiGel on women's sexual activity and desire. Results were presented in October 2003 at the meeting of the International Society for the Study of Women's Sexual Health in Amsterdam.

October 20, 2003

Eli Lilly reported positive new data from a serious of clinical trials investigating Cialis (tadalafil), a PDE5 inhibitor for the treatment of erectile dysfunction. Results demonstrated that 62% of men who underwent bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP) reported improved erections after taking the drug. Data showed that 82% of men attempted intercourse at least once between four hours and up to 36 hours after taking the drug over a 12-week period. The trial was a phase III multi-center enrolling 303 men who had undergone surgery 12-48 months pre-study. The most commonly reported drug related adverse events were headache, upset stomach and muscle ache. Results were presented at the annual meeting of the Sexual Medicine Society in Denver.

September 22, 2003

Proctor & Gamble and Watson reported the results of a phase II trial investigating their testosterone patch for the treatment of Hypoactive Sexual Desire Disorder (HSDD). Results showed that the group treated with 300 µg/day testosterone patch experienced a 30% greater increase in the frequency of satisfying sexual activity, as recorded in a Sexual Activity Log (SAL), compared to placebo. The 150 µg/day group showed no significant benefit versus placebo, and the 450 µg/day group showed no advantage over the 300 µg/day group. The 24-week, randomized, double blind study enrolled 447 subjects and was designed to evaluate the safety and efficacy of the testosterone patch in women HSDD resulting from the surgical removal of both ovaries. Subjects received either 150, 300 or 450 µg/day testosterone patch or placebo. Final survival data from D9901 is anticipated to be available in late 2004 to early 2005.

July 7, 2003

Auxilium reported positive results from a phase IV trial investigating Testim, a testosterone gel for the treatment of hypergonadism in older men with diabetes. Results showed that treatment with Testim had significant improvements in sexual performance and lean body mass without any changes in exercise. Subjects treated with Testim also experienced a decline in glucose levels. In addition, data revealed that these subjects showed greater improvements in lean body mass, spontaneous erections, sexual desire and sexual performance as compared to patients treated with a transdermal patch or placebo. The 90-day study enrolled 406 hypogonadal men with a mean age of 58 years and Testim gel (50-100 mg/day) to a commercially available transdermal patch and placebo gel. Testosterone levels were measured in blood samples taken over a 24-hour period. Results were presented at The Endocrine Society's 85th Annual Meeting in Philadelphia.<

June 16, 2003

Nastech reported mixed results from a phase II trial investigating intranasal apomorphine, a dopamine agonist for the treatment of female sexual dysfunction. Results showed that in women taking intranasal apomorphine (0.5 mg) a statistically significant improvement from baseline was achieved in many areas including, sexual relationship satisfaction, overall sexual life satisfaction, arousal frequency, arousal intensity and maintaining the aroused state. Data demonstrated however, that the difference between apomorphine and placebo treatments did not reach statistical significance. The study enrolled 38 pre-menopausal women who had been diagnosed with female sexual arousal disorder. Adverse events in both the apomorphine and placebo groups were generally mild with no observations of flushing, nausea, vomiting, hypotension or syncope.

NexMed reported positive results from two pivotal phase III trials investigating Alprox-TD, a alprostadil transdermal cream for the treatment of erectile dysfunction (ED). Results demonstrated that the three dose levels of Alprox-TD tested were effective over placebo in each study and in the combined analysis of the two studies. All doses showed a highly significant increase in Erectile Function Domain scores using the International Index of Erectile Function (IIEF), the standard for measuring efficacy in ED products. The side effects reported were mostly mild to moderate, localized and transient. The overall discontinuance rate due to side effects was less than 4%. The randomized, double blind, placebo-controlled studies enrolled over 1,700 subjects with mild to severe ED and were conducted at 85 sites in the U.S.

June 9, 2003

Nastech reported mixed results from a phase II trial investigating intranasal apomorphine, a dopamine agonist for the treatment of female sexual dysfunction. Results showed that in women taking intranasal apomorphine (0.5 mg) a statistically significant improvement from baseline was achieved in many areas including, sexual relationship satisfaction, overall sexual life satisfaction, arousal frequency, arousal intensity and maintaining the aroused state. Data demonstrated however, that the difference between apomorphine and placebo treatments did not reach statistical significance. The study enrolled 38 pre-menopausal women who had been diagnosed with female sexual arousal disorder. Adverse events in both the apomorphine and placebo groups were generally mild with no observations of flushing, nausea, vomiting, hypotension or syncope.

May 5, 2003

Lilly reported positive results from a phase III trial investigating Cialis (tadalafil), a phosphodiesterase type five inhibitor for the treatment of erectile dysfunction (ED). Results showed that 79% of subjects treated with Cialis reported improved erections, as determined by the Global Assessment Question, compared with 19% on placebo. Data also demonstrated that 77% of attempts at penetration were successful for subjects on Cialis, as recorded in the Sexual Encounter Profile diary compared with 43% on placebo. In addition, men taking Cialis were able to complete 64% of sexual intercourse attempts compared with 23% for men taking placebo. The 12-week, randomized, placebo-controlled study enrolled 207 subjects in the U.S. and Puerto Rico.

April 28, 2003

NexMed reported positive results from a pilot study investigating alprostadil/lidocaine/NexACT, a topical cream combination for the treatment of premature ejaculation (PE). The primary efficacy measure was ejaculatory latency time (ELT). Results showed that the ELT increased to more than 2 minutes in 53.5% of all subjects in the treatment group compared with only 12.5% subjects in the control group. The secondary efficacy endpoints included the degree of satisfaction of both subject and partner. Results showed that the sexual satisfaction of subjects and their partners in the treatment group, reached 72.1% and 67.4%, respectively. No satisfaction was reported from either subjects or their partners in the control group. The 3-month, multi-center, single-blind study enrolled 51 PE subjects with a mean age of 37.7 years and PE symptom duration of 4.5 years.

June 3, 2002

Preliminary phase II trial results suggest that NexMed's Femprox topical cream, which utilizes alprostadil and the NexACT platform drug delivery technology, may be an effective treatment for women with female sexual arousal disorder (FSAD). The multicenter, randomized, placebo-controlled, double-blind, "at home use" trial was designed to evaluate Femprox in 98 pre-menopausal women with FSAD. Subjects were required to administer treatment up to ten times during the four-week trial. Data showed positive dose-related trends, with up to a 77% response rate observed at the highest dose in subjects who reported arousal at least 50% of the time and who attempted intercourse at least three times during the trial.

February 25, 2002

Positive results were reported from a phase I trial of PT-141, Palatin Technologies' medication for male and female sexual dysfunction. The double-blind, placebo-controlled trial evaluated escalating doses of PT-141 in 88 healthy male subjects. Results indicated that both intranasally and subcutaneously administered PT-141 were well tolerated over a range of doses. Neither dosage form produced serious side effects, and a maximum tolerated dose could only be reached with subcutaneous dosing. Additionally, subjects who received PT-141 at effective dose levels had erections sufficient for sexual intercourse (as defined by RigiScan Plus System score) for a duration of more than one hour relative to placebo.

December 10, 2001

Positive results were reported from a phase II trial of Alista, Vivus' topical formulation of alprostadil (prostaglandin E1) for the treatment of female sexual dysfunction. The double-blind, placebo-controlled trial included 79 subjects with a primary complaint of female sexual arousal disorder. The trial was conducted at six sites, and Alista was administered in the clinic in conjunction with visual sexual stimulation. Results showed significant differences between the responses to Alista and placebo in terms of the level of sexual arousal, patient satisfaction with the level of arousal and the level of sexual satisfaction. These differences were observed as early as five minutes after dosing, and were maintained throughout the period of sexual stimulation. Alista was well tolerated at all doses administered in the trial.