Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorWalter Reed National Military Medical Center

About this trial

Study the change in serum estrogen level based on the method of vaginal cream application (applicator vs fingertip application) and Measure patient satisfaction with vaginal estrogen cream application based on the method of application using a validated patient questionnaire (Likert scale).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients who are postmenopausal for at least 1 year (since their last menses)

patients who qualify for treatment with vaginal estrogen cream and are willing to complete the treatment

English speaking patients

patients should be able to self-apply the vaginal estrogen cream using the applicator method and the fingertip application

Disqualifiers

pre and perimenopausal women

contraindication to estrogen therapy (Deep vein thrombosis, history or active cancer)

women who are not able to self apply the vaginal estrogen cream

vaginal bleeding of unknown origin

Trial design

Design model

Parallel

Treatments tested in this trial

  • application of the vaginal estrogen cream

    Drug

    patients will apply the vaginal estrogen cream

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: vaginal estrogen application in post-menopausal women by fingertip useActive comparator 1 intervention
Group B: vaginal estrogen application in post-menopausal women by applicator useActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Measure the change in the level of serum estrogen in postmenopausal women based on the method of application of the estrogen cream (fingertip vs applicator use).

Time frame
6-8 weeks

Secondary outcomes

1

Measure patient satisfaction with vaginal estrogen cream application based on the method of application using a validated patient questionnaire (Likert scale).

Time frame
6-8 weeks
2

Measure improvement in sexual dysfunction with application of the vaginal estrogen cream based on the method of application using a validated patient questionnaire (Female sexual function index).

Time frame
6-8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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