Evidence map›Paper›PMID 25998936›Full record

ArticleContraception2015

Assessing the potential of the Woman's Condom for vaginal drug delivery.

Lindsay F Kramzer, Jessica Cohen, Jesse Schubert, Charlene S Dezzutti, Bernard J Moncla, David Friend, Lisa C Rohan

Open access · greenAbstract read
In one paragraph

Article in Contraception, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Pipeline for contraceptive development.Fertility and sterility · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Lindsay F KramzerDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
Jessica CohenPATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA.
Jesse SchubertPATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA.
Charlene S DezzuttiDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
Bernard J MonclaDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
David FriendCONRAD, 1911 North Fort Myer Drive Suite 900, Arlington, VA, 22209, USA.
Lisa C RohanDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA; Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA. Electronic address: rohanlc@upmc.edu.
Craft Engineering Associates (United States) · USProgram for Appropriate Technology in Health · USContraception Research and Development · USMagee-Womens Research Institute · US

Funding

Pharmaceutical and Regulatory CoreU19AI082639 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI FRIEND, DAVID R · 2010 to 2014
$13.0M
NIAID NIH HHS U19 AI082639
6 · The paper itself

Abstract

backgroundThe Woman's Condom is a new female condom that uses a dissolvable polyvinyl alcohol capsule to simplify vaginal insertion. This preclinical study assessed the feasibility to incorporate an antiviral drug, UC781, into the Woman's Condom capsule, offering a unique drug delivery platform. STUDY

designUC781 capsules were fabricated using methods from the development of the Woman's Condom capsules as well as those used in vaginal film development. Capsules were characterized to evaluate physical/chemical attributes, Lactobacillus compatibility, in vitro safety and bioactivity, and condom compatibility.

resultsTwo UC781 capsule platforms were assessed. Capsule masses (mg; mean±SD) for platforms 1 and 2 were 116.50±18.22 and 93.80±8.49, respectively. Thicknesses were 0.0034±0.0004 in and 0.0033±0.0004 in. Disintegration times were 11±3 s and 5±1 s. Puncture strengths were 21.72±3.30 N and 4.02±0.83 N. Water content measured 6.98±1.17% and 7.04±1.92%. UC781 content was 0.59±0.05 mg and 0.77±0.11 mg. Both platforms retained in vitro bioactivity and were nontoxic to TZM-bl cells and Lactobacillus. Short-term storage of UC781 capsules with the Woman's Condom pouch did not decrease condom mechanical integrity.

conclusionsUC781 was loaded into a polymeric capsule similar to that of the Woman's Condom product. This study highlights the potential use of the Woman's Condom as a platform for vaginal delivery of drugs relevant to sexual/reproductive health, including those for short- or long-acting HIV prevention. IMPLICATIONS: We determined the proof-of-concept feasibility of incorporation of an HIV-preventative microbicide into the Woman's Condom capsule. This study highlights various in vitro physical and chemical evaluations as well as bioactivity and safety assessments necessary for vaginal product development related to female sexual and reproductive health.

Indexed as

Administration, IntravaginalAnilidesAntiviral AgentsDrug Delivery SystemsDrug Evaluation, PreclinicalFemaleFuransHeLa CellsHumansSingle-Use Internal CondomThioamidesAnilidesAntiviral AgentsFuransThioamidesUC-781ContraceptionHIV preventionMicrobicideTopical preexposure prophylaxisUC781Woman’s Condom

Identifiers

PMID25998936
PMCPMC4563346
OpenAlexW1899589003

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.