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Treatment of Premature Ejaculation with Paroxetine Hydrochloride

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Treatment of Premature Ejaculation with Paroxetine Hydrochloride International Journal of Impotence Research (1999) 11, 241±246 ß 1999 Stockton Press All rights reserved 0955-9930/99 $12.00 http://www.stockton-press.co.uk/ijir Treatment of premature ejaculation with paroxetine hydrochloride CG McMahon1* and K Touma1 1Australian Centre for Sexual Health, St. Luke's Hospital, Sydney, Australia Aims of this study: To evaluate the ef®cacy of chronic and `on demand' administration of paroxetine hydrochloride in the drug treatment of premature ejaculation (PE). Materials and methods: Ninty-four normally potent men, aged 18 ± 61 y (mean 39 y) with premature ejaculation were treated between January 1996 and March 1997, with oral paroxetine hydrochloride, a selective serotonin re-uptake inhibitor (SSRI). All men were either married or in a stable relationship. Sixty-four out of ninety-four men (Group A) were initially treated with paroxetine hydrochloride 20 mg administered once daily. Those men who responded with improved ejaculatory control within four weeks, were then treated with `on-demand' paroxetine hydrochloride (20 mg) administered 3 ± 4 h prior to planned intercourse. The remaining 33 out of 94 men (Group B) were initially treated with `on-demand' paroxetine hydrochloride 20 mg administered 3 ± 4 h prior to planned intercourse. Results: The mean pre-treatment ejaculatory latency time (ELT) of both group A and B was 0.4 min (range 0 ± 1 min) in 205 intercourses at a frequency of 0.4 intercourses PEr week. In group A after four weeks of daily administration of paroxetine, the mean ELT was 4.5 min (range 1- anejac.) in 761 intercourses at a frequency of 2.4 intercourses per week. Fifty-three out of sixty-one men in group A regarded their ejaculatory control as improved and were then treated with `on- demand' paroxetine, achieving an ELT of 3.9 min (range 0 ± 10) in 608 intercourses at a frequency of 2.6 intercourses per week. Thirty-six men in this group of 53 regarded that they had maintained improved ejaculatory control with a mean ELT of 5.5 min (range 2 ± 20 min) after a further four weeks of treatment (P < 0.001). The remaining 17 men reported a recurrence of poor ejaculatory control with a mean ELT of 0.7 min (range 0 ± 2 min). In group B with initial `on-demand' paroxetine after a mean of 4.5 weeks of treatment, the mean ELT was 1.5 min (range 0 ± 5 min) in 298 intercourses at a frequency of 2.2 intercourses per week. Adverse effects were only recorded in men taking daily paroxetine and included anejaculation in 5 out of 61, inhibited orgasm in 3 out of 61 and reduced libido on 3 out of 61. Erectile dysfunction was not reported and `on demand' paroxetine was not associated with any adverse effects. Conclusions: Paroxetine hydrochloride appears to be a useful agent in the pharmacological treatment of premature ejaculation when administered on a chronic, an `on-demand' basis following chronic treatment or initial `on demand' basis. Keywords: premature ejaculation; paroxetine; anti-depressant drugs Introduction sexual counselling as a result of their non-accep- tance of counselling as a valid treatment due to incorrectly assumed social stigma associated with Premature ejaculation (PE) is the most common attending a psychiatrist or psychologist. Some men male sexual disorder, affecting perhaps as many as may be unable or not prepared to devote the time 75% of men at some stage in their sexual lives. required to attend several counselling sessions. Premature ejaculation is invariably psychogenic due Other men may demand a quicker response than to performance anxiety, fear or psychological trauma psychosexual counselling is reported to offer. and has historically been treated predominantly by Optimal results with psychosexual counselling are psychosexual counselling. However, many men highly dependant on the cooperation of the sexual decline or fail to complete a trial of psychosexual partner of the man in attending and actively counselling as treatment for PE for a variety of participating in the counselling sessions. Many reasons. Men may decline treatment with psycho- men do not have a current sexual partner or may have a non-compliant sexual partner. Clearly, a signi®cant treatment `hiatus' exists in the manage- ment of PE which may be ®lled by alternate non- *Correspondence: Dr CG McMahon, Australian Centre for Sexual Health, St. Luke's Hospital, Sydney, Australia. counselling treatment methods. Received 26 August 1998; accepted in revised form 10 Delayed ejaculation is a common adverse effect of September 1999 many psychotropic and antidepressant drugs which Treatment of premature ejaculation CG McMahon and K Touma 242 act centrally and=or locally to retard the psycho- commencement of the study using a stop watch neurological control of ejaculation and subsequent operated by the patient. All patients enrolled in the orgasm. Animal studies have shown that the central study had an ELT less than 1 min and were regarded neurotransmitter serotonin has an inhibitory effect as having severe PE. on sexual function, while dopamine is generally Premature ejaculation was regarded as ejaculation stimulatory.1 Sexual effects can occur through any that occurred within 60 s of intromission. Men with shift in this serotonin-dopamine balance by an erectile dysfunction, reduced sexual desire, inhib- increase or decrease in either or both neurotrans- ited male orgasm, chronic psychiatric or physical mitter. The serotonin re-uptake inhibitors (SSRI) illness, alcohol or substance abuse and the use of should reduce sexual arousal and have a bene®cial medication, including psychotropic medication effect on premature ejaculation. were excluded from the trial. Men were asked not There have been multiple reports in the literature to use condoms, topical penile anaesthetic creams or regarding the sexual adverse effects of antidepres- sprays. None of the men received any formal sant drugs and their potential use as treatment for psychosexual counselling. PE. Deveaugh-Geiss et al 2 in a multi-centre study Men in this study were enrolled into two groups, reported failure of ejaculation in 42% of 520 men group A and group B. Men enroled in group A treated for depression with 200 mg chlomi- initially received paroxetine 20 mg daily for four pramine=d. Monteiro et al 3 reported a double blind weeks (Phase 1). Men in Group A who responded study which showed even greater sexual dysfunc- with improved ejaculatory control were then treated tion in depressed men treated with chlomipramine, with a single dose of paroxetine (20 mg) adminis- among 17 men, ejaculation was delayed in three and tered `on demand' 3 ± 4 h prior to planned inter- absent in 14. Girgis et al 4 and Althof et al 5 reported course (Phase 2) for a further four weeks. Men success in the actual treatment of PE with chlomi- enrolled in group B received only a single dose of pramine. paroxetine (20 mg) administered `on demand' 3 ± 4 h Patterson6 noted retarded or absent ejaculation in prior to all intercourses during a period of four 45 out of 60 male men treated with 20 mg=d weeks. ¯uoxetine for depression. Kara et al 7 in a double Men were supplied with an ejaculation diary and blind placebo controlled study of ¯uoxetine demon- were asked to record their frequency of coitus, strated a seven fold increase in the ejaculatory quality of erection and orgasm, and to measure and interval which was noted as early as one week after record their ejaculatory latency time using a stop- initiation of treatment. Crenshaw8 reported a dose watch. Men were required to attempt coitus on at related improvement in ejaculatory control in 46 least two occasions each week. men with ¯uoxetine treatment of PE. He noted that some men maintained improved ejaculatory control after withdrawal of ¯uoxetine after 3 ± 6 months of Statistical analysis treatment. Waldinger et al,9,10, Giammusso et al 11 and Ludovico et al 12 reported signi®cant improve- ment in ejaculatory control with paroxetine. McMa- A Student's t-test was used to compare the ELT hon,13 Swartz14 and Mendels et al 15 have all before and after treatment with paroxetine in Groups reported a consistently bene®cial effect of sertraline A and B in the treatment of premature ejaculation. This paper reports the results of a prospective open label dose study of the ef®cacy of paroxetine Results hydrochloride (Aropax1, SmithKline Beecham In- ternational-Pharmaceuticals) administered chroni- cally and `on-demand' in the treatment of PE. The mean age of the 94 men studied was 39 y (range 18 ± 61 y). The mean pre-treatment ejaculatory latency time was 0.4 min (range 0 ± 1 min). The pre- Materials and methods treatment frequency of intercourse was 0.4 times= week. Fifty-®ve men (59%) had lifelong premature ejaculation, the remaining 39 men (41%) describing Ninety-four normally potent men suffering from PE acquired premature ejaculation with previous ac- were enrolled in a prospective study to assess the ceptable ejaculatory control. Of the 55 men with ef®cacy and tolerance of paroxetine hydrochloride lifelong premature ejaculation, 10 men (18%) had (Aropax1) in the management of PE. All of the study severe lifelong premature ejaculation and had never group were heterosexual, had no other sexual achieved intravaginal ejaculation. disorders and were either married or in a stable Group A comprised 61 men with a mean age of relationship. Baseline pre-treatment ELT was deter- 40 y (range 22 ± 61), 37 men having lifelong PE and mined as the mean of measurements at a minimum the remaining 24 having acquired PE. Group B of two intercourses (mean 2.2, range 2 ± 3) prior to comprised 33 men with a mean age of 37 y (range Treatment of premature ejaculation CG McMahon and K Touma 243 18 ± 56), 18 men having lifelong PE and the remain- ELT (P < 0.001).
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