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Postmenopausal Pessary Users: Estrogen Versus Trimosan

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Terminated
Phase 4

Conditions

Vaginosis
Vaginosis, Bacterial
Vaginal Discharge

Treatments

Drug: Estrogen vaginal cream
Drug: Trimo-San vaginal gel

Study type

Interventional

Funder types

Other

Identifiers

NCT03943823
HSC-MS-15-0337

Details and patient eligibility

About

The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.

Enrollment

4 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
  • Is a new pessary user, or has not had a pessary for a year

Exclusion criteria

  • Pregnancy
  • Persistent Bacterial Vaginosis infection in the first two clinic encounters
  • Currently on hormone replacement therapy
  • Previously on hormone replacement therapy in the past 6 months
  • Currently on antibiotics
  • Patients with existing vaginal erosions/ulcerations

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Estrogen vaginal cream
Active Comparator group
Treatment:
Drug: Estrogen vaginal cream
Trimo-San vaginal gel
Active Comparator group
Treatment:
Drug: Trimo-San vaginal gel

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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