Trial reportClimacteric : the journal of the International Menopause Society2016
Pharmacokinetic studies of solubilized estradiol given vaginally in a novel softgel capsule.
Trial report in Climacteric : the journal of the International Menopause Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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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.
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.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systemic estradiol levels with low-dose vaginal estrogens.Menopause (New York, N.Y.) · 2020Pooled it
- Physical characteristics and properties of estradiol softgel vaginal inserts.Menopause (New York, N.Y.) · 2020Trial
- Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women.Journal of women's health (2002) · 2017Trial
- TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol.Menopause (New York, N.Y.) · 2017Trial
- Case-Based Perspectives on the Management of Genitourinary Syndrome of Menopause.Clinics and practice · 2026Review
- Application of Sol-Gels for Treatment of Gynaecological Conditions-Physiological Perspectives and Emerging Concepts in Intravaginal Drug Delivery.Gels (Basel, Switzerland) · 2022Review
- WISDOM survey: attitudes and behaviors of physicians toward vulvar and vaginal atrophy (VVA) treatment in women including those with breast cancer history.Menopause (New York, N.Y.) · 2019Article
- Genitourinary syndrome of menopause - is the problem solved? State of the art 2018.Przeglad menopauzalny = Menopause review · 2018Review
- Current treatment options for postmenopausal vaginal atrophy.International journal of women's health · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the bioavailability and safety of a novel vaginal capsule containing solubilized bioidentical 17β-estradiol for vulvar and vaginal atrophy and compare its pharmacokinetics with that of an approved vaginal estradiol tablet in healthy postmenopausal women.
methodsTwo randomized, single-dose, two-way cross-over, relative bioavailability trials compared the pharmacokinetics of a solubilized vaginal estradiol softgel capsule (TX-004HR, test) with that of a vaginal estradiol tablet (Vagifem®, reference) in postmenopausal women (aged 40-65 years) at 10-μg and 25-μg doses. In each study, women were randomly assigned to receive a single dose of the test capsule or reference tablet, followed by a single dose of the alternate drug after a 14-day washout.
resultsThirty-five women completed the 10-μg study and 36 completed the 25-μg study. Significantly lower systemic levels of estradiol, estrone, and estrone sulfate at both doses of the test product were observed compared with equivalent doses of the reference product, with lower AUC0-24 and Cmax and earlier tmax. No adverse events were reported in either trial.
conclusionTX-004HR, a novel estradiol vaginal softgel capsule, exhibited significantly lower systemic exposure than equivalent doses of an approved vaginal estradiol tablet at both 10-μg and 25-μg doses. Both doses of each product were safe and well-tolerated.
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