Dirk Janssens

Sexual Functioning in Women Using Levonorgestrel‐Releasing Intrauterine Systems as Compared to Copper Intrauterine Devices

INTRODUCTION There has been little research published on the impact of intrauterine contraceptive (IUC) methods on sexual functioning. AIMS This study aimed: (i) to assess different aspects of sexual functioning, including the prevalence of sexual dysfunction in women using a levonorgestrel intrauterine system (LNG-IUS); (ii) to compare this prevalence with that among copper-releasing intrauterine device (Cu-IUD) users; and (iii) to identify the relationship between psychological variables and sexual functioning in women using one of the aforementioned IUCs. METHODS In a multicenter cross-sectional study, 845 women with an IUC were invited to fill out a questionnaire. The latter was returned by 402 (48%) of them: 353 women were LNG-IUS users (88%) and 49 were Cu-IUD users (12%). The questions asked pertained to depression, well-being, marital relation quality, and sexual functioning. MAIN OUTCOME MEASURES Sexual functioning was measured with the short sexual functioning scale. RESULTS One-third of LNG-IUS users (33%) reported a sexual dysfunction. Of those, 20% reported an increased sexual desire, 25% a decreased sexual desire, 5% arousal problems, and 8% orgasm problems. Women using a LNG-IUS did not differ significantly in distribution, type, or prevalence (32.9% vs. 36.7%) of sexual dysfunction, nor in depressive symptoms (Beck Depression Inventory score; 4.7 vs. 3.9; P = 0.33), general well-being (WHO-5 well-being scale score; 16.8 vs. 17.7; P = 0.170), or partner relationship quality (Dyadic Adjustment Scale score; 107 vs. 108; P = 0.74) compared to Cu-IUD users. Overall, the perceived influence of IUCs on sexual functioning was in the lower range and did not differentiate LNG-IUS greatly from Cu-IUD-users. CONCLUSION Women using a LNG-IUS do not differ from those wearing a Cu-IUD with regard to psychological and sexual functioning. The perceived impact of IUD use on sexuality should not be overestimated.

The Femilis LNG-IUS: contraceptive performance-an interim analysis.

Objective To provide an update on the experience with the Femilis® levonorgestrel-releasing intrauterine system (LNG-IUS) used for up to five years by parous and nulliparous women, particularly with regard to its contraceptive performance. Study design An interim, open, prospective non-comparative study of the Femilis® LNG-IUS releasing 20 μg of levonorgestrel/day. Results Two-hundred and eighty insertions were carried out in women with a mean age of 35.7 years (range 17–48), 60% of whom were parous and 40% nulliparous. Twenty-four women with uterine pathology (e.g., fibroids, menorrhagia) were included in the study. The cumulative gross discontinuation life table rates were determined. The total observation period was 8,028 woman-months. The LNG-IUS was easy to insert in 95.7% of the cases, and no perforations occurred. No pregnancies were observed and only one expulsion took place (rate 0.4/100 women at five years). The cumulative total use-related discontinuation rate was 14.7/100 at five years. There were nine removals because of pain, six of which were in nulliparous women. Four women requested removal of the IUS for bleeding problems. Fourteen removals were done for ‘other’ medical reasons among which mood disturbances (five cases) were the most frequent, and 12 for non-medical reasons. Fifteen removals were requested for pregnancy wish. Twelve of these women became pregnant within one year and all had uneventful pregnancies. The Femilis® LNG-IUS was equally well accepted by nulliparous as by parous women. Most women with heavy menstrual bleeding prior to insertion, whether associated with fibroids or not, reported much less bleeding, scanty bleeding or even no bleeding at all after insertion. Conclusion This study suggests that the Femilis® LNG-IUS, which releases 20 μg LNG/d, is a highly effective, well tolerated and well retained contraceptive both in parous and nulliparous women. The shorter crossarm of the LNG-IUS has simplified its insertion technique, which may contribute to its safety. This could promote use by non specialist providers and enhance the application of the method.

Development of a miniature, low-dose, frameless intrauterine levonorgestrel-releasing system for contraception and treatment: a review of initial clinical experience

A low-dose levonorgestrel (LNG)-releasing intrauterine system (IUS) (FibroPlant) has been clinically developed since 1997 for endometrial suppression during hormone replacement therapy in peri- and postmenopausal women, for the treatment of menorrhagia in women with normal uteri or with uterine fibroids, for contraception, for the treatment of endometrial hyperplasia, and for alleviating primary and secondary dysmenorrhoea. Results of preliminary studies confirm the promising nature of this all-round drug delivery system. The low dose of LNG released accounts for the low hormonal side-effect rate and virtual absence of amenorrhoea in premenopausal women. The system has not yet been evaluated in tamoxifen users (to protect the endometrium), or in women with rectovaginal endometriosis. However, early indications suggest that the system will also be suitable for these indications. The frameless drug delivery support of this LNG-releasing IUS has been optimized to reduce the size of the foreign body and to maximize tolerance and continuation of use while simultaneously providing for the maximum duration of action.

Intrauterine levonorgestrel delivered by a frameless system, combined with systemic estrogen: acceptability and endometrial safety after 3 years of use in peri- and postmenopausal women.

Objective. To evaluate the acceptability and endometrial safety of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), combined with estrogen therapy (ET) in 150 peri- and postmenopausal women, followed-up for at least 3 years. Design. This was a prospective, non-comparative study in peri- and postmenopausal women. In the majority of women, treatment with the FibroPlant-LNG intrauterine system (IUS), combined with ET, was initiated during the perimenopausal transitional phase to establish a smooth transition to menopause and suppress the endometrium to prevent endometrial proliferation and bleeding. A 3.5-cm long coaxial fibrous delivery system, delivering approximately 14 μg LNG/day, was used. The calculated duration of release of the system is at least 3 years. The majority of women received percutaneous 17β-estradiol (Oestrogel®), 1.5 mg daily on a continuous basis, which provides sufficient blood levels of estrogen in most women to suppress climacteric symptoms and protect against bone loss. Outcome measures. To measure acceptability, women were asked, after they had the IUS in place for a minimum of 3 years, if they would like to continue the combined regimen and if they would accept renewal of the IUS. Endometrial safety was evaluated by transvaginal ultrasound examination and endometrial biopsy in a subset of 101 women prior to replacement of the IUS. Results. Ninety-four insertions were done in perimenopausal and 56 in postmenopausal women aged between 33 and 78 years. Of the total group of 150 women, 132 women (88.0%) accepted replacement of the IUS and ten are waiting for replacement. This group includes nine women who will receive a second replacement. The number of women continuing the method is 142 (94.6%). Histological examinations conducted on endometrial biopsies from 101 postmenopausal women prior to replacement, after an average period of use of the regimen of 40 months (range 25–50 months), showed predominantly inactive endometrium characterized by pseudodecidual reaction of the endometrial stroma with endometrial atrophia, which is in keeping with the effects seen with a progestogenic compound. There were no specimens showing signs of proliferation. Conclusions. Results suggest that the frameless FibroPlant-LNG IUS is safe, well tolerated, well accepted and effective in suppressing the endometrium during ET. Intrauterine progestogen administration in postmenopausal women can be regarded as fundamentally advantageous compared with systemically applied progestogens, which may have potentially inherent ill side-effects, especially on the breast and cardiovascular system, as reported in the recent literature.

Adolescent Intrauterine Contraception: IUD Size and Comfort during Insertion are Essential (IUD use in adolescents)

Background: Unintended pregnancies and induced abortion in adolescent women are soaring. The use of longacting reversible contraceptives (LARC), particularly the intrauterine device (IUD) and implant, are advocated as they don’t require daily adherence. Objective: To provide expert advice on the use of IUDs in young nulliparous and adolescent women in order to maximize continuation of use of the method. Results: Clinical studies suggest that high continuation of use of an IUD can be achieved by giving attention to the geometric relationship between the IUD and the host uterine cavity. Frameless IUDs virtually eliminate pain complaints and embedment caused by too large IUDs resulting often in early discontinuation. Conclusion: Appropriate intrauterine devices could enhance continuation of use and result in fewer unintended pregnancies and induced abortions. It is imperative to attach importance to comfort during device insertion to motivate young women to use the method.