Evidence map›Paper›PMID 27181790›Full record

Trial reportWomen's health (London, England)2016

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

Anita H Clayton, Stanley E Althof, Sheryl Kingsberg, Leonard R DeRogatis, Robin Kroll, Irwin Goldstein, Jed Kaminetsky, Carl Spana, Johna Lucas, Robert Jordan and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Women's health (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01382719 (A Placebo-controlled, Randomized, Parallel Group, Dose-finding Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With FSAD), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
10.5field-weighted citation impact, top 1% 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.

NCT01382719 phase2completednot on this map

A Placebo-controlled, Randomized, Parallel Group, Dose-finding Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With FSAD (Female Sexual Arousal Disorder) and/or HSDD (Hypoactive Sexual Desire Disorder)

TypeinterventionalSponsorPalatin Technologies, IncRan2011 to 2012Enrolled612ConditionsFemale Sexual Arousal Disorder, Hypoactive Sexual Desire DisorderArmsbremelanotide
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 99 citations in OpenAlex.

  1. Trial
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  15. Article
  16. Review
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  18. Article
  19. Sexual Health in Menopause.Medicina (Kaunas, Lithuania) · 2019
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Anita H ClaytonUniversity of Virginia, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA.
Stanley E AlthofCase Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
Sheryl KingsbergUniversity Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
Leonard R DeRogatisMaryland Center for Sexual Health, 1300 York Road, Lutherville, MD 21093, USA.
Robin KrollSeattle Women's Health, Research, Gynecology, 3216 NE 45th Place, Seattle, WA 98105, USA.
Irwin GoldsteinSan Diego Sexual Medicine/Alvarado Hospital & Medical Center, 6655 Alvarado Road, San Diego, CA 92120, USA.
Jed KaminetskyManhattan Medical Research, 215 Lexington Avenue, New York, NY 10016, USA.
Carl SpanaPalatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
Johna LucasPalatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
Robert JordanPalatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
David J PortmanColumbus Center for Women's Health Research, 99 North Brice Road, Columbus, OH 43213, USA.
Palatin Technologies (United States) · USColumbus Center · USManhattan Medical Research · USPomerado Hospital · USSeattle Reproductive Medicine · USUniversity Hospitals Case Medical Center · USUniversity of Virginia · USUniversity School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimEvaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.

methodsPatients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm.

resultsEfficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache.

conclusionIn premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).

Indexed as

alpha-MSHDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLibidoMiddle AgedPeptides, CyclicSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalTreatment OutcomeWomen's Healthalpha-MSHbremelanotidePeptides, Cyclicbremelanotidefemale sexual arousal disorderfemale sexual dysfunctionFSDHSDDhypoactive sexual desire disorder

Identifiers

PMID27181790
PMCPMC5384512
OpenAlexW2394917144

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.