Human Reproduction Vol.20, No.4 pp. 1100–1106, 2005 doi:10.1093/humrep/deh686 Advance Access publication December 17, 2004

Effects of two types of —oral versus intravaginal—on the sexual life of women and their partners

Maurizio Guida, Attilio Di Spiezio Sardo1, Silvia Bramante, Stefania Sparice, Giuseppe Acunzo, Giovanni Antonio Tommaselli, Costantino Di Carlo, Massimiliano Pellicano,

Elena Greco and Carmine Nappi Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021

Dipartimento di Ostetricia, Ginecologia e Fisiopatologia della Riproduzione Umana, Universita` di Napoli ‘Federico II’, Via Pansini 5, 80131 Napoli, Italia 1To whom correspondence should be addressed. E-mail: [email protected]

BACKGROUND: Data relating to the influence of hormonal contraception on sexual life are conflicting and mostly they refer to oral contraceptives. In this randomized, controlled, prospective study we compared the effect of an intravaginal hormonal contraceptive with the effect of a combined oral contraceptive on sexual function. METHODS: Fifty-one healthy women with a permanent partner and an active sexual life were randomly divided in two groups according to a computer-generated randomization list: 26 women (group A) used an intravaginal contraceptive releasing 120 mg/day of and 15 mg/day of ethinylestradiol (EE) and 25 women (group B) used an oral contraceptive containing 20 mg di EE and 150 mg of desogestrel. Twenty-five women participated in the study as control group (group C). A specific questionnaire was completed by the patients and their partners at the start of the study and after cycles 3 and 6 of contraceptive use. RESULTS: Within 3 months of contraceptive use, women from both groups A and B reported a global improvement in sexual function. A statistically significant increase in sexual fantasy was reported only by patients of group A. Whereas partners of the women in both groups A and B reported an improvement in sexual function after 3 months of contraceptive intake, only patients’ partners of group A reported a significant increase in sexual interest, complicity and sexual fantasy. CONCLUSIONS: Both hormonal contraceptives tested were seen to have a positive effect on some aspects of sex- ual function. The intravaginal contraceptive ring seems to exert a further positive effect on the psychological aspect of both women and their partners, which is evident from an improved complicity and sexual satisfaction.

Key words: intravaginal hormonal contraceptive/oral hormonal contraceptive/partners/sex life

Introduction 120 mg of etonogestrel and 15 mg of EE daily. The ring can Forty years after their introduction, hormonal contraceptives be easily inserted within the 5th day of the menstrual cycle, still represent the most effective reversible method for family deep into the , into the posterior fornix; it remains in planning. In recent years, to reduce side-effects associated place for 21 days and is then removed for a 7 day ring-free with the contraceptive administration, the dosage of ethiny- period. lestradiol (EE) has been gradually reduced from 50 mgto Clinical trials showed that Nuvaring is an effective contra- 20–15 mg and new progestogens have been introduced with a ceptive with a high rate of satisfaction, good cycle control reduced androgenic activity and low side-effects. The most- and high tolerability among users (Roumen and Dieben, used hormonal contraceptives are administered by the oral 1999; Dieben et al., 2002; Novak et al., 2003, 2004). route and need daily administration, 21–24 days per cycle Data related to the influence of hormonal contraception on (Borgelt-Hansen, 2001). sexual life are conflicting and they mostly refer to oral con- However, women have recently shown an increased inter- traceptives. Some studies showed that women who take oral est towards hormonal contraception that does not require hormonal contraceptives have a higher frequency of sexual daily intake (den Tonkelaar and Oddens, 2001). intercourse compared to women who use other contraceptive Recently, an intravaginal contraceptive device has been methods, with an increased frequency and intensity of developed (Nuvaring; Organon, The Netherlands), which pre- orgasms (Wynn et al., 1975; Trussell and Westoff, sents a ring structure, flexible and transparent, that releases 1980; Oddens, 1999) while others have shown that oral

1100 q The Author 2004. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. Hormonal contraception and sexual life contraceptives are associated with negative effects on libido examination, Papanicolaou test, evaluation of blood pressure, calcu- and reduced women’s sexual activity (Graham et al., 1995; lation of the BMI and complete haematochemical tests. Sanders et al., 2001; Caruso et al., 2004). During the pre-treatment phase, each woman underwent three or As no studies are available in the literature focusing four ultrasonographic evaluations between days 10 and 16 of the specifically on NuvaRing influence on users’ and their part- menstrual cycle; follicles with a diameter .15 cm were monitored until breaking or until disappearance, to evaluate the presence of a ners’ sexual life, we decided to perform such a study compar- normal ovulatory cycle and the absence of pelvic or adnexal ing this intravaginal contraceptive with a combined oral pathologies. contraceptive. One hundred and sixteen out of 265 women met the inclusion cri- teria and were enrolled. Seventy-three women wanted to start hor- monal contraception. Randomization into two groups was refused Materials and methods by 17 women and so the remaining 56 women were randomly All women who came to the Clinic of our Depart- divided into two groups according to a computer-generated ran- ment, between August 2003 and December 2003, were asked to par- domization list: 28 women (group A) were assigned to Nuvaring, 28 ticipate in the study for the valuation of hormonal contraceptive women (group B) to an oral contraceptive containing 20 mgofEE Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021 influence on users’ and their partners’ sexual activity. and 150 mg of desogestrel (Mercilon; NV Organon) (Figure 1). Ran- The participants had to be between 22 and 34 years of age, had to domization sequence was concealed both to researchers and patients have reached the age of menarche between 12 and 14 years, have a until interventions had been assigned. body mass index (BMI) between 20 and 22 kg/m2, have an active Twenty-eight out of 43 patients unwilling to start hormonal con- sexual life ($4 vaginal intercourses in the last month without any traception were randomly chosen according to a computer-generated specific complaint regarding it at the admission visit) with an habit- randomization list to take part in this study as control group ual partner (.1 year), have no abnormal menstrual cycles nor (group C). abnormal dietary requirements. The effects of each contraceptive on sexuality of the study group Definitive exclusion criteria included confirmed pregnancy or sus- were evaluated for a time-period of 6 months from the beginning of picion thereof, pregnancy or breastfeeding in the previous year, evi- the study. dence of acute, chronic or progressive hepatic disease, evidence of The study was approved by the local ethics committee, and was vascular or metabolic disorders, .10 cigarettes per day, history of performed in accordance with the Declaration of Helsinki Guide- migraine with aura, use of psychotropic drugs, use of drugs known lines on Human Experimentation. Informed consent was obtained to influence the pharmacokinetics of contraceptive steroids, use of from all the enrolled patients. hormonal contraceptives in the previous year, hysterectomy or Group A patients were instructed about the modality of insertion oophorectomy and all other clinically relevant contraindications for of the intravaginal contraceptive ring, deep into the posterior fornix the use of hormonal contraception. of the vagina, on the 5th day of menstrual cycle and instructed to Before inclusion in the protocol, all the women provided a medi- keep it there for 21 days. The removal of the ring was followed by cal and gynaecological history and underwent a gynaecological a ring-free period of 7 days. Group B patients were instructed to

Figure 1. Flow diagram of patients enrolled in the study. 1101 M.Guida et al. take the contraceptive pill on the first day of the menstrual cycle for The differences between the three groups in mean DVAS and in 21 days, followed by a pill-free period of 7 days. baseline VAS score were statistically evaluated by Mann–Whitney The effects of both types of hormonal contraceptives on the sex- test for independent variables. The intra- and inter-group differences ual activity of patients was assessed by the Interviewer Ratings of in weekly frequency of were statistically evalu- Sexual Function (IRSF) which evaluates some psychological and ated by Wilcoxon test and Mann–Whitney test respectively. Statisti- physical aspects of sexual interactions (Bancroft et al., 1982; Tyrer cal significance was set at P , 0.05. et al., 1983). The IRSF is a semi-structured interview involving a standard opening question for each item, followed by further probe questions as necessary to allow the interviewer to make the rating. Results We used a modified version of the IRSF in our study as the inter- The study group consisted of 76 women. Two patients from viewer had to ask a standard opening question but then the patients group A and three patients from group B discontinued the and their partners had to rate their score for each question on a contraceptive use for spotting, headaches and fluid retention. visual analogue scale (VAS) of 100 mm (range 0–100). The IRSF was carried out on the women and their partners for Two patients of group C were excluded from statistical ana- groups A and B at the baseline and after cycles 3 and 6 of contra- lysis as they missed a scheduled visit and one patient due to Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021 ceptive intake. The same questions were asked to patients of group pregnancy (Figure 1). C and their partners at the baseline and after spontaneous cycles 3 There were no differences between the three groups at and 6. baseline in terms of age, BMI, duration of relationship with The calculated differences in VAS score (DVAS) between base- partner, level of education, number of children, previous con- line (VAS0), cycle 3 (VAS3) and cycle 6 (VAS6) were used to traceptives used and weekly frequency of sexual activity evaluate the effects of the contraceptive use on sexual function for (Table I). Data regarding the 17 patients willing to start hor- each patient for each parameter (primary outcomes) investigated monal contraceptive but who refused the randomization pro- through the questionnaire. The calculated differences were: cess are given in Table II. No significant differences were DVAS ¼ VAS –VAS ; DVAS ¼ VAS –VAS ; and DVAS ¼ 1 3 0 2 6 0 3 detected between these women and the three studied groups VAS6 –VAS3. In addition, weekly frequency of sexual activity (secondary out- in terms of baseline characteristics. come) of all patients was evaluated. Furthermore women of group A At the baseline there were no significant differences and their partners were asked if they could feel the intravaginal ring between the patients of the three groups in terms of par- during sexual intercourse. ameters investigated by IRSF (Table III). We calculated that, to observe a significant difference (P , 0.05) The modification of these parameters in patients of the in the variation of the parameters of sexual function with 95% stat- three groups during the six months is reported in Table III. istical significance, a sample of 20 patients in each group would be Improvement of sexual function in women of groups A needed. and B after 3 months of contraceptive intake, compared to The Shapiro–Wilk’s test was performed to evaluate the distri- group C, is demonstrated by the positive values in DVAS1 bution of data for all parametric variables. Age, BMI and the dur- of some parameters expressing positive sexual function ation of partners’ current relationships showed a normal distribution, (pleasure, satisfaction, complicity, sexual interest, frequency and differences between groups at the beginning of the study for these variables were evaluated by Student’s t-test for unpaired data. and intensity of orgasms) and by the negative values in The data for level of education, number of children and methods of DVAS1 of some parameters expressing negative sexual contraception previously used showed a non-normal distribution and function (anxiousness, pain and discomfort). In both groups therefore the differences between the groups for these variables A and B a significant difference was reached only for were calculated by Mann–Whitney test. some parameters (anxiousness, sexual pleasure, frequency

Table I. Baseline characteristics of the patients Characteristics Group A Group B Group C P

Age (years) 30.6 ^ 2.4 31.3 ^ 0.8 29.5 ^ 1.3 NS Body mass index (kg/m2) 21.7 ^ 0.3 21 ^ 0.6 21.4 ^ 0.2 NS Duration of present relationship (years) 5 ^ 1.5 4.5 ^ 0.9 4.9 ^ 1.3 NS No. of children 1 ^ 0.8 1.3 ^ 0.9 1.2 ^ 0.6 NS Weekly frequency of sexual intercourse 2.8 ^ 0.9 3.1 ^ 1.2 3.0 ^ 1.1 NS Level of education (n) None – 1 – NS School diploma 5 3 4 NS High school diploma 16 15 14 NS Degree 5 6 7 NS Contraceptive methods in the last year (n) None 4 5 3 NS Coitus interruptus 8 6 9 NS Natural methods 5 4 2 NS 6 8 9 NS 3 2 2 NS

Data are expressed as mean ^ SD unless otherwise stated. NS ¼ not significant. 1102 Hormonal contraception and sexual life

Table II. Baseline characteristics of the 17 patients willing to start hormonal 10.2 12.1 13.7 7.4 11.1 5.3 6.1 5.6 10.1 9.3 8.2 2 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ contraception but refused the randomization process ^ 1.2 3.0 1.8 1.8 0.2 0.8

Characteristics VAS D 2 2 2 2 2 2 Age (years) 30.1 ^ 1.4 Body mass index (kg/m2) 21.6 ^ 0.2 Duration of present relationship (years) 5.1 ^ 1.0 7.78.7 1.2 17.0 9.110.04.5 5.5 1.6 1.0 5.2 4.8 7.3 0.4 No. of children 0.9 ^ 1.1 8.5 1.2 1 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ Weekly frequency sexual intercourse 3.0 ^ 1.3 ^

Level of education (n) 0.2 1.0 2.2 0.2 0.4 1.6 VAS

None – D 2 2 2 2 2 2 School diploma 2

High school diploma 11 25) Degree 4 ¼ Contraceptive methods in the last year (n) n 14.7 17.5 13.2 14.4 16.713.4 16.3 1.8 15.6 1.0 9.6 0.1 7.4 1.1 14.2 0.4

None 3 Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ Coitus interruptus 6

Natural methods 2 Baseline 37.6 62.8 52.0 55.7 54.4 65.0 53.1 Condom 5 Intrauterine device 1

Reason for refusing randomization (n) c c d c c c d Personal choice 10 12.1 13.2 12.8 12.3 10.5 18.3 10.1 13.8 36.2 10.2 20.4 8.7 14.2 Do not feel confident with the idea of 4 9.9 32.4 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ using an endovaginal contraceptive 2 1.8 Do not feel confident with the 3 0.9 19.2 18.6 27.2 23.8 20.2 15.2 22.7 VAS 2 2

idea of using the pill D 2 . 0 Data are expressed as mean ^ SD unless otherwise stated. –VAS c c d c c c d 6 10.2 11.6 14.1 14.913.6 14.9 11.0 21.7 7.3 7.5 6.9 10.8 2.6 VAS ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ 1 ¼ 2 and intensity of orgasm, satisfaction, sexual interest, com- 1.8 23.0 VAS 2 D 2

plicity). In addition a significant increase in sexual fantasy VAS D was reported in patients of group A, compared to groups B ; 0 25) Group C (

and C. ¼ n

Sexual interest and complicity were significantly different –VAS 12.6 15.511.3 17.5 14.715.517.5 15.5 13.4 7.5 14.6 23.9 21.7 18.8 13.2 9.9 0.1 6.9 10.4 1.0 3 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ between groups A and B. A significant increase in the num- ^ ber of sexual intercourses in group A and B was noted at VAS Baseline 46.3 61.0 49.5 31.5 51.6 53.4 64.0 53.9 ¼ cycle 3 (group A, 4.3 ^ 1.2 versus 2.8 ^ 0.9, P , 0.001; 1 ^ ^ group B, 4.4 1.2 versus 3.1 1.2, P , 0.001) and at cycle VAS D 6 (group A, 4.4 ^ 1.0 versus 2.9 ^ 0.8, P , 0.001; group B, c c bc ac c c c bc 13.0 19.6 16.7 10.3 18.4 15.5 12.5 12.0 17.4 14.4 10.9 14.9 4.5 ^ 0.8 versus 3.1 ^ 1.2, P , 0.001) in comparison with 15.6 38.8 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ basal values and with group C at cycle 3 (group A versus 2 3.5 ^ ^ 4.2 20.9 28.0 34.4 26.6 24.2 25.8 30.6 group C, 4.3 1.3 versus 2.9 1.0, P , 0.001; group B 23.7 VAS 2 2 versus group C, 4.4 ^ 1.2 versus 2.9 ^ 1.0 P , 0.001) and D 2 at cycle 6 (group A versus group C, 4.4 ^ 1.8 versus ^ ^

3.0 1.0, P , 0.001; group B versus group C, 4.5 0.8 c c bc ac c c c bc versus 3.0 ^ 1.0, P , 0.001). No significant differences were 8.5 13.0 8.6 18.6 15.5 11.1 17.0 14.5 11.0 13.6 2.1 14.6 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ observed between groups A and B at cycles 3 and 6 of con- ^ 1

traceptive intake in terms of weekly frequency of sexual 2.2 3.04 21.4 VAS 2 2 D intercourse. 2 Improvement of sexual function remained nearly constant 26) Group B ( after 6 months of contraceptive use without significant differ- ¼ n 9.8 1.97.9 20.8 16.414.214.9 29.0 19.0 21.4 23.8 28.0 15.4 25.0 10.4 10.7 0.36 ences compared to cycle 3. 10.9 25.2 ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ As a result of their partners being in the contraceptive ^ groups, sexual functions of the male partners were modified SD. Visual analogue score Group A ( Baseline ^ as shown in Figure 2. After 3 months of contraceptive intake, a significant reduction in anxiety and an increase in pleasure and satisfaction, frequency and intensity of orgasm were reported in partners of patients in groups A and B. In the partners of patients in group A, a significant increase in sex- Effects of contraceptive use on sexual function of women in groups A and B compared to group C difference in visual analogue score (for full definitions see Materials and methods).

ual interest, complicity and sexual fantasy was noted com- ¼ 0.05 versus group B. 0.01 versus group C. pared to the partners in the other groups. Like the women in 0.001 versus group B. 0.001 versus group C. , , , , VAS P P P P Table III. Discomfort 22 a b c d Evaluation parameter of sexual function D Sexual pleasurePainSexual fantasies 57.9 Intensity of orgasmSatisfactionComplicity 34 16.6 51.8 Data are expressed asGroup mean A: intravaginal hormonal contraceptive; group B: combined oral 61.4 contraceptive; 54.2 Orgasm 53.3 Anxiousness 44.7 Personal initiative 36.0 the study, the improvement of sexual function in the male Sexual interest 51.6 1103 M.Guida et al.

Estrogens increase blood flow to the brain and the vagina, increase vibratory sensation peripherally and have a positive effect on nerve growth and nerve transmission (Berman and Goldstein, 2001); levels of estradiol ,50 pg/ml have been correlated with sexual complaints (Sarrel, 1990). Testosterone seems to play a central role in controlling sex drive through receptor-mediated activities. In fact the hypo- thalamus, which controls sexual function and mood, contains dense estrogen and testosterone receptors (DeCherney, 2000). On the other hand, progesterone seems to have an inhibi- tory effect on human sexuality: the pre-menstrual progester- one fall is associated with an increase of peri-menstrual desire, at least in women not suffering from pre-menstrual Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021 syndrome (Graziottin, 2000). It is conceivable that hormonal contraceptives might mod- ify the neuroendocrine pattern in women, affecting their Figure 2. Effects on partners’ sexual function with an intravaginal sexuality. Available data refer to oral hormonal contracep- hormonal contraceptive and a combined oral contraceptive. tives but are interpreted in different ways. Indeed, some *P , 0.001 versus group B; §P , 0.001 versus group C. Group A: studies report a higher frequency of sexual intercourse, fre- intravaginal hormonal contraceptive; group B: combined oral quency and intensity of orgasm in women who take oral con- contraceptive; group C: controls. traceptives compared to controls (Wynn et al., 1975; Trussell and Westoff, 1980) and to other contraceptive methods (Oddens, 1999). In particular, positive effect on sexual life was observed in 44% of oral contraception users compared to 11, 28 and 36% of other contraceptive method users such as , natural methods and intrauterine device (Oddens, 1999). The mechanism of the presumed positive action of hor- monal contraception on sexual activity is still unclear. The psychological safety reassurance resulting from use of a very effective method of contraception reduces the fear of an unwanted pregnancy and therefore increases desire and sexual satisfaction (Masters and Johnson, 1987). It is poss- ible to observe an increased compliance with less negative effects on the sexual life of a woman who uses an effec- tive and safe method of contraception (Oddens, 1999). Therefore, these positive effects on sexual function could Figure 3. Percentage of women and their partners feeling the intravaginal ring during sexual intercourse. stem from the ability to separate sexual activity for procreation purposes from that of pleasure (Egarter et al., partners showed a substantial consistency after 6 months of 1999). therapy compared to cycle 3 of contraceptive intake. On the contrary, other authors have demonstrated how oral The number of couples in group A who reported feeling contraceptives have a negative effect on the libido and sexual the intravaginal ring during sexual intercourse is shown in function in women (Graham et al., 1995; Sanders et al., Figure 3. 2001; Caruso et al., 2004). These effects, however, seem to be temporary (Graham et al., 1995). The mechanism of negative influence on the sexual Discussion activity of the user are still unclear. In any case, dryness of Human sexuality depends on complex interactions among the vagina due to the reduction of EE dosage of the new con- cognitive processes, neurophysical and biochemical mechan- traceptive pill, and the hypoandrogenism due to the increase isms and mood (Bancroft, 1988; Basson, 2000). of sex hormone-binding globulins, with the consequent Several organs are vital to a normal sexual response: the reduction in free testosterone level, seem to be the basis for brain, however, is the centre of the sexual universe. The five libido reduction (Coenen et al., 1996). In addition the new senses (smell, sight, sound, taste, touch) help to relay sexual contraceptive pills contain a new generation of progestins images, fantasies and ideas to the brain. The brain accepts which have a reduced androgenic activity compared to the these signals and translates them into messages the body can antecedent. understand. These messages include signals to increase blood The influence of contraception on sexual life is an import- flow and release sex hormones, such as estrogen, testosterone ant factor when deciding upon the choice of method of and vasoactive substances (Walton and Trashawn, 2003). contraception by women (Graham et al., 1995). 1104 Hormonal contraception and sexual life

A new intravaginal hormonal contraceptive ring the male with positive effects on sexual interest and on the (Nuvaring) was recently introduced; because of the position expectation concerning sexual intercourse. of the ring in the vagina during sexual intercourse, an A possible explanation for this finding may be that part- influence on sexual activity of the users and their partners ners were aware of a ‘foreign body’ inside the partner’s could be envisaged. vagina, eliciting psychological excitation rather than the In our study it was possible to observe a significant physical sensation of touching it. On the other hand, it cannot reduction in anxiousness relating to sexual activity, both in be excluded that the sensation of touching the ring may posi- the women and their partners, in both groups using contra- tively affect the partner’s sexuality because the ring ception compared to control group. In addition, a significant represents a reminder of the hormonal protection against increase in the frequency of sexual intercourse, pleasure and unintended pregnancies. satisfaction, complicity, sexual interest and intensity of However, due to the inability of eliciting a true measure of orgasm was observed in both groups using contraception the presence of a placebo-effect (i.e. presence of a plastic compared to the control group. Improvement in sexual func- ring in the vagina) and the impact of the different hormones Downloaded from https://academic.oup.com/humrep/article/20/4/1100/701081 by guest on 24 September 2021 tion in the partners of the two groups using contraception and their levels in the two groups using contraception, a was observed. The positive effects are similar to previous definitive conclusion regarding the main cause of the studies, stressing the strong effect of psychological reassur- observed intergroup differences cannot be drawn from this ance resulting from use of very effective contraception study. methods, which has notably improved the sexual function of In conclusion, the use of both hormonal contraceptives users and partners (Masters and Johnson, 1987; Egarter et al., tested seems to have a positive effect on some aspects of sex- 1999). ual function in the users and their partners. Moreover, the We are aware that our study has several limitations. First, intravaginal contraceptive ring, which is as effective as other the major limitation of the present study is the lack of pla- contraceptives, seems to implement a further positive effect cebo-controlled groups. Enrolling a sufficient number of sub- on the psychological aspect of both women and their jects unwilling to use hormonal contraception but keen to partners, which is evident from an improved complicity and accept the use of a hormone-less would have sexual satisfaction. been difficult. Another limitation of our study is that the control group was not randomized; however, the 28 subjects of group C References were chosen from a group of 43 subjects according to a Bancroft J (1988) Sexual desire and the brain. Sex Marital Ther 3,11–27. computer-generated randomization list. Bancroft J, Tyrer G and Warnwr P (1982) The assessment of sexual pro- Finally we do not feel that the lack of blinding of both blems in women. Br J Sex Med 9,30–37. Basson R, Berman J, Burnet A, Derogatis L, Ferguson D, Fourcroy J, users and interviewers could have affected the results. Indeed Goldstein I, Graziottin A, Heiman J, Laan E et al. 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