Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

NCT03493126 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2018H0006
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the postpartum period with those using placebo.

Conditions

Vaginal Atrophy

Keywords

postpartum, local estrogen

Outcome Measures

Primary Outcomes (1)

• Vulvar Assessment Scale (VUAS)

  The VUAS is a four-item measurement administered by a clinical provider that quantifies and rates the patient's responses to questions of dryness, soreness, irritation and pain to external stimulation. Patients are asked whether they have experienced specific symptoms ("yes/no") during the past 4 weeks and rate symptom severity ("none," "mild," "moderate," "severe"). The first 3 items assess dryness, soreness, and irritation during routine activities excluding sexual intercourse and the fourth item assesses pain with external manual stimulation. An option for "no attempt" indicates a patient has not been sexually active within the past 4 weeks. Each item in the VuAS is scored from 0 (none) to 3 (severe) with composite scores calculated by taking the mean of the items when at least two of four items are not missing. Higher scores indicate worse symptoms. The minimum composite score is 0 and maximum composite score is 3.

  3 months

Secondary Outcomes (6)

• Depression

  3 months

• Urinary Symptoms

  3 months

• Fecal Incontinence

  3 months

• Sexual Function

  3 months

• Satisfaction Via Likert Scale

  3 months

Study Arms (2)

Estradiol

EXPERIMENTAL

Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.

Drug: Estradiol

Placebo

PLACEBO COMPARATOR

Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.

Other: Placebo

Interventions

Estradiol DRUG

17β-estradiol vaginal cream

Also known as: Estrace

Estradiol

Placebo OTHER

Compounded placebo cream

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females \>18 years old with at least one prior prenatal care appointment affiliated with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status post \>37 weeks and 0 day vaginal delivery with at least a second degree perineal laceration; English-speaking and able to provide informed consent.

You may not qualify if:

• allergies to estradiol cream or its constituents; a vaginal delivery associated with a intrauterine fetal demise or neonatal death; inability to complete questionnaires in English or comply with study protocol; and inability to apply vaginal cream independently. The following medical conditions and diagnoses are also exempted: undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active arterial thromboembolic disease, known liver dysfunction or disease, known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Sponsors & Collaborators

• Ohio State University: lead
• International Urogynecological Association: collaborator

Study Sites (1)

The Ohio State University Urogynecology Clinic

Columbus, Ohio, 43215, United States

Location

Related Publications (5)

• Tennfjord MK, Hilde G, Staer-Jensen J, Ellstrom Engh M, Bo K. Dyspareunia and pelvic floor muscle function before and during pregnancy and after childbirth. Int Urogynecol J. 2014 Sep;25(9):1227-35. doi: 10.1007/s00192-014-2373-2. Epub 2014 Apr 1.

  PMID: 24687365 BACKGROUND

• Wisniewski PM, Wilkinson EJ. Postpartum vaginal atrophy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1249-54. doi: 10.1016/s0002-9378(12)90737-1.

  PMID: 1659199 BACKGROUND

• Haran C, van Driel M, Mitchell BL, Brodribb WE. Clinical guidelines for postpartum women and infants in primary care-a systematic review. BMC Pregnancy Childbirth. 2014 Jan 29;14:51. doi: 10.1186/1471-2393-14-51.

  PMID: 24475888 BACKGROUND

• Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1147-1156. doi: 10.1097/AOG.0000000000000526.

  PMID: 25415166 BACKGROUND

• Eaton AA, Baser RE, Seidel B, Stabile C, Canty JP, Goldfrank DJ, Carter J. Validation of Clinical Tools for Vaginal and Vulvar Symptom Assessment in Cancer Patients and Survivors. J Sex Med. 2017 Jan;14(1):144-151. doi: 10.1016/j.jsxm.2016.11.317. Epub 2016 Dec 20.

  PMID: 28011209 BACKGROUND

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Andrew Hundley
• Organization: The Ohio State University

andrew.hundley@osumc.edu

614-293-4647

Study Officials

• Andrew F Hundley, MD

  The Ohio State University, Female Pelvic Medicine and Reconstructive Surgery

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 10, 2018
• Study Start: October 15, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 22, 2021
• Results First Posted: December 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)