Evidence map›Paper›PMID 38232942›Full record

ArticleContraception2024

Successful postcoital testing of Ovaprene: An investigational non-hormonal monthly vaginal contraceptive.

Christine Mauck, Andrea Thurman, Jeffrey T Jensen, Courtney A Schreiber, Jeff Baker, Melody Y Hou, Steven Chavoustie, Clint Dart, Hongsheng Wu, Nadene Zack and 2 more

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Contraception, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.7field-weighted citation impact, top 12% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Trial
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

12 authors at 9 institutions in 1 country.

Christine MauckDaré Bioscience, Inc., San Diego, CA, United States. Electronic address: cmauck@darebioscience.com.
Andrea ThurmanDaré Bioscience, Inc., San Diego, CA, United States; Formerly of Eastern Virginia Medical School, Norfolk, VA, United States.
Jeffrey T JensenDepartment of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.
Courtney A SchreiberDepartment of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States.
Jeff BakerClinical Research Prime, Idaho Falls, ID, United States.
Melody Y HouDepartment of Obstetrics and Gynecology, University of California Davis, Sacramento, CA, United States.
Steven ChavoustieSegal Institute for Clinical Research Inc., Miami, FL, United States.
Clint DartPremier Research, Morrisville, NC, United States.
Hongsheng WuPremier Research, Morrisville, NC, United States.
Nadene ZackFormerly of Daré Bioscience, Inc., San Diego, CA, United States.
Jessica HathewayDaré Bioscience, Inc., San Diego, CA, United States.
David FriendDaré Bioscience, Inc., San Diego, CA, United States.
Bioscience Research · USPremier Research Group · USDart NeuroScience (United States) · USEastern Virginia Medical School · USIdaho National Laboratory · USOregon Health & Science University · USSegal Institute for Clinical Research · USUniversity of California, Davis · USUniversity of Pennsylvania · US

Funding

Safety, and acceptability of a non-hormonal vaginal ringR44HD095724 · NICHD · DARE BIOSCIENCE, INC. · PI MAUCK, CHRISTINE · 2018 to 2020
$1.9M
NICHD NIH HHS R44 HD095724
6 · The paper itself

Abstract

objectiveEvaluate reduction in progressively motile sperm per high power field (HPF) in midcycle cervical mucus after intercourse with Ovaprene: an investigational monthly non-hormonal vaginal contraceptive consisting of a vaginal ring and mechanical barrier, releasing spermiostatic ferrous gluconate. STUDY

designOpen-label, multicenter study enrolling heterosexually-active women with previous permanent contraception. Participants underwent a baseline postcoital test cycle with no device to confirm the presence of sperm, followed by one diaphragm postcoital test cycle, one Ovaprene safety cycle, and two Ovaprene postcoital test cycles. In each postcoital test cycle, participants underwent a midcycle cervical mucus evaluation to confirm an Insler score ≥10 and absence of sperm, and then returned two to four hours after vaginal intercourse for repeat cervical mucus evaluation. We considered <5 progressively motile sperm/HPF indicative of preliminary contraceptive effectiveness.

resultsWe enrolled 38 participants; 23 completed the study. All participants had ≥5 progressively motile sperm/HPF in the baseline cycle and <5 progressively motile sperm/HPF in all 49 Ovaprene cycles and all 35 diaphragm cycles, meeting the definition of a successful postcoital test. This was true regardless of examiner blinding, prior vaginal delivery or vaginal ring use, body mass index, or dislodgements noted by the participant or investigator. The mean of 27.2 (±17.9) progressively motile sperm/HPF in baseline postcoital test cycles was reduced to 0.5 (±1.1) and 0.5 (±1.3) progressively motile sperm/HPF in the first and second Ovaprene cycles, respectively. Ovaprene fit all participants and all could insert, position, and remove it.

conclusionUse of Ovaprene resulted in meeting the prespecified criterion for contraceptive effect by all participants during all postcoital test cycles. IMPLICATIONS: The finding that use of Ovaprene, an investigational monthly non-hormonal vaginal contraceptive, resulted in postcoital testing of cervical mucus that met the pre-specified definition of success (<5 progressively motile sperm/HPF) supports further evaluation of contraceptive efficacy of the device in users at risk for pregnancy.

Indexed as

Contraceptive Devices, FemaleSemenBody Mass IndexContraceptive AgentsFemaleHumansMalePregnancyVaginaContraceptive AgentsContraceptionContraceptiveOvaprenePostcoital testVaginal

Identifiers

PMID38232942
PMCPMC11152141
OpenAlexW4390887109

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.