The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

NCT00803335 | Completed Phase 3

• 1 other identifier: 08135-08-076
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Conditions

Pelvic Organ Prolapse; Vaginal Atrophy

Keywords

pelvic organ prolapse; vaginal atrophy; atrophic vaginitis; postmenopausal; posthysterectomy; vaginal health; vaginal cytology; vaginal maturity index; vaginal histology; quality of life questionnaires

Outcome Measures

Primary Outcomes (1)

• Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.

  baseline and 2-12 weeks after treatment (at time of surgery)

Secondary Outcomes (1)

• Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.

  baseline and 2-12 weeks after treatment (at time of surgery)

Study Arms (3)

Premarin cream 0.5gm

ACTIVE COMPARATOR

Application of 0.5gm of vaginal estrogen cream nightly until surgery.

Drug: Vaginal conjugated estrogen cream 0.5gm

Premarin cream 1.0gm

ACTIVE COMPARATOR

Application of 1.0gm of vaginal estrogen cream nightly until surgery.

Drug: Vaginal conjugated estrogen cream 1.0gm

No intervention

NO INTERVENTION

Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

Interventions

Vaginal conjugated estrogen cream 0.5gm DRUG

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

Also known as: Premarin

Premarin cream 0.5gm

Vaginal conjugated estrogen cream 1.0gm DRUG

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Also known as: Premarin

Premarin cream 1.0gm

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 45 years or older
• Postmenopausal (\>55 if natural menopause)
• Clinical atrophic vaginitis (at least mild atrophy)
• Pelvic organ prolapse(at least stage 2 or greater)
• Posthysterectomy
• Surgery date between 2-12 weeks after recruitment

You may not qualify if:

• Uterus present
• Well-estrogenized appearing vagina
• Known or suspected history of breast carcinoma
• Hormone-dependent tumor
• Genital bleeding of unknown cause
• Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
• Vaginal infection requiring treatment
• Allergy to estrogen or its constituents
• Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
• Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
• Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.

  PMID: 37431855 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Atrophic Vaginitis

Interventions

Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Christine M Vaccaro, DO

  Good Samaritan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 27, 2015

Record last verified: 2014-02

Locations

US (1)