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Record W3006546353 · doi:10.1016/j.jsxm.2019.12.013

Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women

2020· review· en· W3006546353 on OpenAlex
Tami S. Rowen, Susan R. Davis, Sharon J. Parish, James A. Simon, Linda Vignozzi

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueThe Journal of Sexual Medicine · 2020
Typereview
Languageen
FieldMedicine
TopicSexual function and dysfunction studies
Canadian institutionsWomen's Health Research Institute
FundersAllerganBayer HealthCareMyovant SciencesIpsenIpsen BiopharmaceuticalsNew England Research InstitutesAbbVie
KeywordsTestosterone (patch)Hypoactive sexual desire disorderConfoundingClinical trialMedicineRegulatory agencySexual medicineReproductive healthAgency (philosophy)Clinical psychologyGynecologySexual desireInternal medicinePopulationHuman sexualityEnvironmental health

Abstract

fetched live from OpenAlex

INTRODUCTION: Testosterone has been studied for its benefits on sexual health for decades. The research regarding testosterone in women has produced evidence that this is a potential treatment for women suffering from female sexual dysfunction. There are several limitations of the testosterone trials that can affect their interpretation and challenges posed by some regulatory agencies that have prevented approval of any testosterone treatment for women in several countries. AIM: To summarize the challenges of testosterone trials in terms of study populations, patient-reported outcomes, validated instruments in research, confounders, and regulatory barriers. METHODS: A thorough review of published data on testosterone for the treatment of women's sexual health problems was undertaken. A detailed evaluation of the limitations of these trials was conducted and incorporated with the published evidence on the regulatory processes involved in moving testosterone from clinical research to drug approval. MAIN OUTCOME MEASURE: Main outcome measures are assessment of clinical trial populations, survey tools, confounders, and regulatory barriers. RESULTS: There is some heterogeneity of study populations included in testosterone trials in women. Similarly, there have been differences in instruments used to assess patient-reported outcomes and often minimal control for potential confounders. The regulatory agency had posed a challenge to approve any testosterone treatment for women based on unproven concerns and a lack of regulatory guidance for drug developers. CLINICAL IMPLICATIONS: There is strong evidence that shows testosterone is effective for treating sexual health concerns in the women included in clinical trials. STRENGTH & LIMITATIONS: Strengths include thorough review of published literature and trial design for sexual health concerns. Limitations include being restricted to English Language publications and not having access to unpublished clinical trial data. CONCLUSIONS: Testosterone trials in women have been limited by homogeneity in the study populations and outcomes measured. Drug development has been hampered by inconsistent regulatory barriers. Rowen TS, Davis SR, Parish S, et al. Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2020;17:585-594.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.006
metaresearch head score (Gemma)0.004
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.977
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0060.004
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0040.000
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.619
GPT teacher head0.467
Teacher spread0.153 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it