Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding

Dahiya, Pushpa; Dalal, Monika; Yadav, Anu; Dahiya, Kiran; Jain, Shuchi; Silan, Vijay

doi:10.1016/j.ejogrb.2016.05.009

Cited by 13 publications

(10 citation statements)

References 18 publications

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“…Menstrual bleeding was the most frequently reported VR opportunity cost, with 11 studies (nine of which involved hormonal APIs) reporting on breakthrough bleeding, withdrawal bleeding, duration of menses, and other bleeding outcomes. RCTs largely reported improved bleeding outcomes (breakthrough bleeding, spotting, intended bleeding patterns) [28, 30, 32, 37, 59, 94]; comparable bleeding outcomes between active VRs and comparison products (Pictorial Blood Loss Assessment Chart scores, duration of menses, and intermenstrual and breakthrough bleeding) [28, 32, 64, 94]; or, no instances of abnormal vaginal bleeding [60]. An observational study reported that VR users had less frequent ‘normal bleeding,’ and significantly higher levels of amenorrhea compared to IUD users; however, it is unknown whether amenorrhea was acceptable to users [27].…”

Section: Resultsmentioning

confidence: 99%

“…Many studies reported non-API side effects of VR use related to vaginal discharge or vaginitis. All RCTs reported low levels of vaginal discharge and there were no significant differences between VR and comparison groups [28, 30, 32, 37, 52, 64, 74]. In seven additional observational studies for contraception and pelvic organ prolapse, 10 to 33% of women reported increased or excessive vaginal discharge [31, 38, 77, 80], and 2.5 to 3.8% of women reported vaginitis [29, 36, 42].…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis

et al. 2019

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The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220). Of 1,110 records identified, 68 met inclusion criteria. Studies included women 15–50+ years from 25 LMIC for indications including HIV prevention, contraception, abnormal bleeding, and menopause. Overall VR acceptability was high (71–98% across RCTs; 62–100% across observational studies), with 80–100% continuation rates in RCTs and favorable ease of insertion (greater than 85%) and removal 89–99%). Users reported concerns about the VR getting lost in the body (8–43%), although actual expulsions and adverse events were generally infrequent. Most women disclosed use to partners, with some worrying about partner anger/violence. The VR was not felt during intercourse by 70–92% of users and 48–97% of partners. Acceptability improved over time both within studies (as women gained VR experience and worries diminished), and over chronological time (as the device was popularized). Women expressed preferences for accessible, long-acting, partner-approved methods that prevent both HIV and pregnancy, can be used without partner knowledge, and have no impact on sex and few side effects. This review was limited by a lack of standardization of acceptability measures and study heterogeneity. This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use; and, that many would consider the VR an acceptable future delivery device for HIV prevention or other indications.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis

et al. 2019

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“…IVRs are advantageous drug delivery systems because they capitalize on the highly vascularized tissue that facilitates drug uptake and avoids the first-pass metabolism; they are also easy to use, long acting, and are not coitally dependent [ 22 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 ]. Moreover, IVRs are established as contraceptive devices [ 113 , 114 , 115 , 116 ], are amenable to a wide range of applications, compatible with many APIs, are women controlled, and are an appealing tool for MPT development.…”

Section: Vaginally Delivered Mptsmentioning

confidence: 99%

Multipurpose Prevention Technologies: Oral, Parenteral, and Vaginal Dosage Forms for Prevention of HIV/STIs and Unplanned Pregnancy

Young

Benhabbour

2021

Polymers

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There is a high global prevalence of HIV, sexually transmitted infections (STIs), and unplanned pregnancies. Current preventative daily oral dosing regimens can be ineffective due to low patient adherence. Sustained release delivery systems in conjunction with multipurpose prevention technologies (MPTs) can reduce high rates of HIV/STIs and unplanned pregnancies in an all-in-one efficacious, acceptable, and easily accessible technology to allow for prolonged release of antivirals and contraceptives. The concept and development of MPTs have greatly progressed over the past decade and demonstrate efficacious technologies that are user-accepted with potentially high adherence. This review gives a comprehensive overview of the latest oral, parenteral, and vaginally delivered MPTs in development as well as drug delivery formulations with the potential to advance as an MPT, and implementation studies regarding MPT user acceptability and adherence. Furthermore, there is a focus on MPT intravaginal rings emphasizing injection molding and hot-melt extrusion manufacturing limitations and emerging fabrication advancements. Lastly, formulation development considerations and limitations are discussed, such as nonhormonal contraceptive considerations, challenges with achieving a stable coformulation of multiple drugs, achieving sustained and controlled drug release, limiting drug–drug interactions, and advancing past preclinical development stages. Despite the challenges in the MPT landscape, these technologies demonstrate the potential to bridge gaps in preventative sexual and reproductive health care.

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“…Band height was held constant at 4.0 mm and thickness of 0.0 (unbanded), 0.3, 0.6, 0.9, and 1.2 mm were explored. The honeycomb unit cell was used to explore the effect of band height (coverage) where band thickness was held constant at 0.6 mm and band height was varied from 3.0, 4.0, 5.0, and 6.0 mm, (6). All generated designs yielded a theoretical volume (mm 3 ) and surface area (mm 2 ).…”

Section: Developing Ivr Design Librarymentioning

confidence: 99%

“…[1] For commercially available IVRs, drug delivery is enabled by API diffusion from the device, through the stratified vaginal mucosal epithelium, and systemically distributed kinetic release profiles associated with IM. [6,23] AM is the selective layering of material in a specified manner, usually dictated by a computationally aided design (CAD) file. The advantages of AM over IM for the fabrication of IVRs include the generation of complex geometries not beholden to a mold, expansion of material choice, and a larger pool of compatible APIs.…”

Section: Introductionmentioning

confidence: 99%

Design and Characterization of a Novel Series of Geometrically Complex Intravaginal Rings with Digital Light Synthesis

Janusziewicz

Mecham

Olson

et al. 2020

Adv Materials Technologies

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Intravaginal rings (IVRs) represent a sustained‐release approach to drug delivery and have long been used and investigated for hormones and microbicides delivery. For decades, IVRs have been manufactured by injection molding and hot‐melt extrusion with very limited design and material capabilities. Additive manufacturing (AM), specifically digital light synthesis (DLS), represents an opportunity to harness the freedom of design to expand control and tunability of drug release properties from IVRs. A novel approach to IVR design and manufacturing is reported that results in geometrically complex internal architectures through the incorporation of distinct unit cells using computationally aided design (CAD) software. A systematic approach is developed to design through the generation of an IVR library and the effects of these parameters are investigated on ring properties. The ability to precisely and predictably control the compressive properties of the IVR independent of the internal architecture with which control of drug release kinetics can be achieved is demonstrated, thus opening the door for a “plug‐and‐play” platform approach to IVR fabrication.

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Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding

Cited by 13 publications

References 18 publications

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis

Multipurpose Prevention Technologies: Oral, Parenteral, and Vaginal Dosage Forms for Prevention of HIV/STIs and Unplanned Pregnancy

Design and Characterization of a Novel Series of Geometrically Complex Intravaginal Rings with Digital Light Synthesis

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