A Phase 4 interventional study of Conjugated equine estrogen topical cream and Apricot kernel oil in Atrophic Vaginitis, Menopause and Recurrent Urinary Tract Infections, sponsored by University of Louisville. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University of Louisville · Phase 4, Interventional, and Basic science
Among 23 studies in Atrophic Vaginitis with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Atrophic Vaginitis · United States.
Among the 23 studies in Atrophic Vaginitis with a site in United States, this one is the 11th largest by enrollment, is the only one that started in 2017, is one of 5 in phase 4, and was the 16th registered.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 110 is above the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →2 of the 23 studies in Atrophic Vaginitis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 4 Atrophic Vaginitis studies recruiting now, 3 (75%) set no upper age limit and 1 (25%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2017.
Median enrollment 69 across the 23 interventional studies. Of the 21 that completed or were terminated, 12 (57%) have results posted.
15 of 23 have an industry lead sponsor. The 10 most frequent:
University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
University of Louisville has 1 study filed under Atrophic Vaginitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Atrophic Vaginitis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause.
This is a study is looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause. The primary objective is to describe the bacterial communities associated in the vagina and urine of postmenopausal women receiving treatment for genitourinary syndrome of menopause with conjugated equine estrogen topical cream (Premarin®) and a nonhormonal alternative (apricot kernel oil). The participants will be randomized to either conjugated equine estrogen topical vaginal cream or apricot kernel oil. They will be given validated questionnaires to assess their urinary and vaginal symptoms, sexual function, quality of life, and impressions of severity and improvement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The conjugated equine estrogen topical vaginal cream 0.5 grams per vagina two times per week at nights for 3 months.
Drug: Conjugated equine estrogen topical cream
One teaspoonful per vagina every night for 3 months.
Drug: Apricot kernel oil
Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.
Also known as: Premarin vaginal cream, Vaginal estrogen cream, CEE topical cream
Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.
Also known as: Natural oil, Organic oil
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.
Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population compared between conjugated equine estrogen cream (Premarin) and apricot kernel oil. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (\>50%) between the estrogen group and the non-estrogen alternative group.
Time frame: 3 months
Change in vaginal symptom questionnaire (VSQ)
Change in vaginal symptoms as assessed by vulvovaginal symptom questionnaire (VSQ) at baseline and after treatment.
Time frame: 3 months
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.
Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population compared between the conjugated equine estrogen cream (Premarin) and apricot kernel oil. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (\>50%) between the baseline patients and the patients at 3 months and compare the change in prevalence in this taxonomic predominance between the two study groups.
Time frame: 3 months
Plan to share: No
Ran from Jan 2017 to primary completion in Jun 2018, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estrogens