A multicenter study of levonorgestrel—Estradiol contraceptive vaginal rings II — Subjective and objective measures of effects

Sivin, Irving; Mishell, Daniel R.; Victor, Arne; Dı́az, Soledad; Alvarez-Sanchez, Francisco; Nielsen, Niels Chr.; Akinla, Oladele; Pyörälä, Tapani; Coutinho, Elsimar Metzker; Faúndes, Aníbal; Roy, Subir; Brenner, Paul F.; Ahren, Tom; Pavéz, Margarita; Brache, Vivian; Giwa-Osagie, O.F.; Fasan, Margaret O.; Zausner-Guelman, Belinha; Darze, Elias; daSilva, Jose Carlos Gama; Dı́az, Juan; Jackanicz, Theodore M.; Stern, Janet; Nash, Harold A.

doi:10.1016/0010-7824(81)90004-4

Cited by 37 publications

(12 citation statements)

References 6 publications

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“…In the early 1980s, Population Council reservoir-IVRs (Jackanicz, 1981) delivering the contraceptive levonorgestrel (LNG) in combination with estradiol (E2) were studied for contraceptive effectiveness and acceptability in multicentered trials involving 1,103 ring users (Sivin et al, 1981a). Increased vaginal discharge, potentially due to alteration of the vaginal microbiome, was identified as the most frequently voiced complaint by users (Sivin et al, 1981a, b). This possibility was disproven by Schwan and colleagues in a group of 17 subjects who used the Population Council LNG-E2 IVR for 6 months (Schwan et al, 1983).…”

Section: Discussionmentioning

confidence: 99%

Comparison of the vaginal microbial communities in women with recurrent genital HSV receiving acyclovir intravaginal rings

et al. 2014

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Vaginally administered antiviral agents may reduce the risk of HIV and HSV acquisition. Delivery of these drugs using intravaginal rings (IVRs) holds the potential benefits of improving adherence and decreasing systemic exposure, while maintaining steady-state drug levels in the vaginal tract. Elucidating how IVRs interact with the vaginal microbiome constitutes a critical step in evaluating the safety of these devices, as shifts the vaginal microbiome have been linked with several disease states. To date, clinical IVR trials have relied on culture-dependent methods that omit the high diversity of unculturable microbial population. Longitudinal, culture-independent characterization of the microbiota in vaginal samples from 6 women with recurrent genital HSV who used an acyclovir IVR was carried out and compared to the communities developing in biofilms on the IVR surface. The analysis utilized Illumina MiSeq sequence datasets generated from bar-coded amplicons of 16S rRNA gene fragments. Specific taxa in the vaginal communities of the study participants were found to be associated with the duration of recurrent genital HSV status and the number of HSV outbreaks. Taxonomic comparison of the vaginal and IVR biofilm communities did not reveal any significant differences, suggesting that the IVRs were not systematically enriched with members of the vaginal microbiome. Device usage did not alter the participants' vaginal microbial communities, within the confines of the current study design. Rigorous, molecular analysis of the effects of intravaginal devices on the corresponding microbial communities shows promise for integration with traditional approaches in the clinical evaluation of candidate products.

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Section: Discussionmentioning

confidence: 99%

Comparison of the vaginal microbial communities in women with recurrent genital HSV receiving acyclovir intravaginal rings

et al. 2014

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“…Other short-term side-effects of the combined ring appear to be slight. Hemoglobin and hematocrit, blood pressure, blood dotting factors, liver function and carbohydrate metabolism are not significantly affected [60].…”

Section: Combined Levonorgestrel-estradiol Vaginal Ringsmentioning

confidence: 89%

“…Vaginal problems -particularly vaginitis, leukorrhea, and other discharge, were significantly more common among women using rings than among OC users. Vaginal problems caused 5-7% of ring users to discontinue the method [60]. Side-effects such as headache, nausea and dizziness were less common among ring users [60].…”

Section: Combined Levonorgestrel-estradiol Vaginal Ringsmentioning

confidence: 99%

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Long-acting progestins — an update

1989

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“…36 When rings of different sizes are directly compared, rings larger in diameter or thickness are associated with fewer expulsions. 3,37 Effects on Vaginal Epithelium and Cervix All CVRs are associated with an increase in vaginal secretions compared to oral contraceptives or no contraception, even when placebo rings are studied. 3,37 The CVR increases vaginal secretions by a weak local inflammatory effect and not by changing the vaginal flora or causing infection.…”

Section: Expulsionsmentioning

confidence: 99%

Contraceptive Vaginal Rings

Harwood¹,

Mishell²

2001

Semin Reprod Med

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Contraceptive vaginal rings (CVRs) contain sex steroids that diffuse through a plastic polymer ring at a constant rate and are absorbed directly through the vaginal epithelium into the systemic circulation. This delivery system provides many advantages over oral contraceptives (OCs), including avoidance of the first-pass effect through the liver, constant serum steroid levels, longer duration of use, and greater bioavailability of the hormones. CVRs containing progestin only are designed for continuous use for 3 to 6 months. Those containing progesterone alone are indicated for use in women who are breastfeeding. Large clinical trials of progestin-containing CVRs demonstrated good efficacy and safety of the CVR, with continuation rates similar to that of OCs. CVRs containing a combination of estrogen and progestin are designed to be used for 1 to 12 months in a cyclic manner similar to OCs, with withdrawal bleeding in the fourth week of each cycle. In clinical trials these CVRs have typical use efficacies similar to OCs, with an acceptable pattern of bleeding.

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A multicenter study of levonorgestrel—Estradiol contraceptive vaginal rings II — Subjective and objective measures of effects

Cited by 37 publications

References 6 publications

Comparison of the vaginal microbial communities in women with recurrent genital HSV receiving acyclovir intravaginal rings

Comparison of the vaginal microbial communities in women with recurrent genital HSV receiving acyclovir intravaginal rings

Long-acting progestins — an update

Contraceptive Vaginal Rings

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