Microdose intravaginal levonorgestrel contraception: A multicentre clinical trial

Koetsawang, Suporn; Gao, Joseph; Krishna, U.; Cuadros, Alvaro; Dhall, G.I.; Wyss, R; Puenta, J.Rodriquez la; Andrade, Arnaldo F.B.; T, Khan; Kononova, E.S.; Lawson, J.P.; Parekh, U.; Elstein, Max; Hingorani, V.; Wang, Na-ning; Yao, Zhong-beng; Landgren, Britt-Marie; Boukhris, R; Lo, Li-lan; Boccard, S.; Machín, David; Pinol, A.; Rowe, P.J.

doi:10.1016/0010-7824(90)90142-i

Cited by 33 publications

(17 citation statements)

References 7 publications

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“…The progesterone and norethisterone rings showed higher than desired side effects (eg, menstrual irregularities) and pregnancy rates,24 so the 90-day LNG IVR was selected for further development, ultimately showing a 3.6% pregnancy rate among women who wore the IVR continuously for 1 year (replacing the IVR every 90 days) 25. While effective, the IVR was firm and relatively inflexible, leading some women to experience expulsion, vaginal abrasions/ulcers and asymptomatic vaginal irritation26,27 and was subsequently redesigned to be smaller and more flexible. The redesigned LNG IVR was shown not to have adverse effects on the vaginal epithelium,28 but a lack of funding precluded further testing.…”

Section: Historymentioning

confidence: 99%

“…This was a silastic ring and was firm and relatively inflexible, requiring 6.4 N to compress the ring28 (thus, approximately fourfold more rigid than the NuvaRing). These physical properties resulted in 29% of women experiencing an unintended expulsion of the IVR in the first year of use, mainly with defecation, urination, or menstruation 26. Repeated unintentional expulsion of the IVR resulted in 7.1% of women discontinuing the product in the first year of use 26.…”

Section: Side Effects Associated With Ivrsmentioning

confidence: 99%

“…These physical properties resulted in 29% of women experiencing an unintended expulsion of the IVR in the first year of use, mainly with defecation, urination, or menstruation 26. Repeated unintentional expulsion of the IVR resulted in 7.1% of women discontinuing the product in the first year of use 26. This bulky IVR was also electively removed by 12% of women, due to vaginal discharge, irritation, vaginal pain, or dyspareunia 26.…”

Section: Side Effects Associated With Ivrsmentioning

confidence: 99%

“…Repeated unintentional expulsion of the IVR resulted in 7.1% of women discontinuing the product in the first year of use 26. This bulky IVR was also electively removed by 12% of women, due to vaginal discharge, irritation, vaginal pain, or dyspareunia 26. The 3.6% pregnancy rate found in the older generation 20 μg/day LNG IVR might have been primarily the result of the high rates of expulsions and removals seen with this less flexible IVR 26.…”

Section: Side Effects Associated With Ivrsmentioning

confidence: 99%

“…This bulky IVR was also electively removed by 12% of women, due to vaginal discharge, irritation, vaginal pain, or dyspareunia 26. The 3.6% pregnancy rate found in the older generation 20 μg/day LNG IVR might have been primarily the result of the high rates of expulsions and removals seen with this less flexible IVR 26. A later trial of 139 women using the early generation silastic IVR found that 35% had erythematous lesions, which were usually asymptomatic 27.…”

Section: Side Effects Associated With Ivrsmentioning

confidence: 99%

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Intravaginal rings as delivery systems for microbicides and multipurpose prevention technologies

Thurman

Clark

Hurlburt³

et al. 2013

IJWH

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There is a renewed interest in delivering pharmaceutical products via intravaginal rings (IVRs). IVRs are flexible torus-shaped drug delivery systems that can be easily inserted and removed by the woman and that provide both sustained and controlled drug release, lasting for several weeks to several months. In terms of women’s health care products, it has been established that IVRs effectively deliver contraceptive steroids and steroids for the treatment of postmenopausal vaginal atrophy. A novel application for IVRs is the delivery of antiretroviral drugs for the prevention of human immunodeficiency virus (HIV) genital infection. Microbicides are antiviral drugs delivered topically for HIV prevention. Recent reviews of microbicide IVRs have focused on technologies in development and optimizing ring design. IVRs have several advantages, including the ability to deliver sustained drug doses for long periods of time while bypassing first pass metabolism in the gut. IVRs are discreet, woman-controlled, and do not require a trained provider for placement or fitting. Previous data support that women and their male sexual partners find IVRs highly acceptable. Multipurpose prevention technology (MPT) products provide protection against unintended/mistimed pregnancy and reproductive tract infections, including HIV. Several MPT IVRs are currently in development. Early clinical testing of new microbicide and MPT IVRs will require a focus on safety, pharmacokinetics and pharmacodynamics. Specifically, IVRs will have to deliver tissue concentrations of drugs that are pharmacodynamically active, do not cause mucosal alterations or inflammation, and do not change the resident microbiota. The emergence of resistance to antiretrovirals will need to be investigated. IVRs should not disrupt intercourse or have high rates of expulsion. Herein, we reviewed the microbicide and MPT IVRs currently in development, with a focus on the clinical aspects of IVR assessment and the challenges facing microbicide and MPT IVR product development, clinical testing, and implementation. The information in this review was drawn from PubMed searches and a recent microbicide/MPT product development workshop organized by CONRAD.

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