Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

NCT01886794 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 13-114
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Conditions

Pelvic Floor Disorders

Keywords

pelvic floor dysfunction; pelvic organ prolapse; vaginal estrogen effects

Outcome Measures

Primary Outcomes (1)

• Vaginal Epithelial Thickness

  Measure of vaginal epithelial thickness obtained by optical coherence tomography

  Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).

Secondary Outcomes (1)

• Histologic Assessment of Excised Tissue

  1 month after visit 1 (3-17days after visit 2)

Study Arms (3)

Postmenopausal, topical vaginal cream

EXPERIMENTAL

Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.

Drug: Postmenopausal, topical vaginal estrogen cream

Pre-menopausal, no topical vaginal cream

NO INTERVENTION

Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.

Postmenopausal, topical placebo cream

PLACEBO COMPARATOR

Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.

Drug: Placebo Comparator: Postmenopausal, topical placebo cream

Interventions

Postmenopausal, topical vaginal estrogen cream DRUG

Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.

Also known as: Estrace vaginal cream

Postmenopausal, topical vaginal cream

Placebo Comparator: Postmenopausal, topical placebo cream DRUG

Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Also known as: Placebo vaginal cream

Postmenopausal, topical placebo cream

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• Stage II or greater pelvic organ prolapse (POP)
• Individuals electing surgery to treat their POP
• Willing and able to comply with study procedures
• Willing and able to provide written informed consent

You may not qualify if:

• Contraindication for estrogen cream
• Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
• History of connective tissue disease
• Previous hysterectomy or pelvic organ prolapse surgery
• Known allergic reaction to any agent required by the protocol
• Use of hormone therapy in postmenopausal women in the last 90 days
• Pregnant or lactating females
• History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

UTMB Galveston

Galveston, Texas, 77550, United States

Location

Related Links

• Link to the clinic where recruitment will be performed

MeSH Terms

Conditions

Pelvic Floor Disorders; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kathleen L. Vincent, M.D.
• Organization: University of Texas Medical Branch

klvincen@utmb.edu

409-772-2610

Study Officials

• Kathleen Vincent, MD

  UTMB Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 26, 2013
• Study Start: June 6, 2013
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-09

Locations

US (1)