The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse

NCT04393194 | Unknown Phase 4 DMC

• 1 other identifier: ZS-2164
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.

Conditions

Pelvic Floor Prolapse

Keywords

Vaginal estrogen cream

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group.

  1. Sustained wearing with satisfaction: continuous wearing is defined as the use of the pessary after successful fitting test. The continuous wearing time interval is from the start of wearing the pessary to cessation of pessary use. 2. PGI-I （patient global impression of improvement））is used to evaluate patient impression of improvement. PGI-I is divided into seven levels: very much better, much better, a little bit better, no change, a little bit worse, much worse and very much worse. The patient's response of" very much better" and" much better" is defined as a successful impression of improvement.

  up to 1year after randomization

Secondary Outcomes (4)

• 1. Comparison of symptom specific distress (PFDI-20) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.

  up to 1year after randomization

• 1. Comparison of symptom specific impact (PFIQ-7) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.

  up to 1year after randomization

• 1. Comparison of sexual function (PISQ-12) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year.

  up to 1year after randomization

• Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year.

  up to 1year after randomization

Study Arms (2)

Vaginal estrogen cream

EXPERIMENTAL

subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

Drug: Vaginal Cream with Applicator [Dose Form]

vaginal placebo cream

PLACEBO COMPARATOR

Subjects will be treated with the prescribed vaginal medication, 1g per time, q d for the first 2 weeks and then 1g per time, twice a week.

Drug: Vaginal Cream with Applicator [Dose Form]

Interventions

Vaginal Cream with Applicator [Dose Form] DRUG

Patients with symptomatic POP will be assigned as outpatients. After the initial pessary fitting, the patients will be followed up in 2 weeks. If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful. Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group. The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.

Also known as: pessary

Vaginal estrogen cream; vaginal placebo cream

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic POP, stage II, stage III or stage IV
• Postmenopausal women (patients with serum FSH\>40lu/L; or amenorrhea for 12 months)
• Successfully fit with ring with support pessary
• Ability to attend the clinical trial and follow-up
• Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent
• Willing and able to place vaginal cream

You may not qualify if:

• Acute infection of internal genital tract
• Hormone replacement therapy in recent 3 months
• Suspected or untreated lower genital tract tumor
• Genital fistula
• Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc)
• Life expectancy less than 1 year
• Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer
• The volume of post-voiding residual is more than 250ml. -

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (2)

• Zhou Y, Yin R, Zhang Y, Wang X, Jin F, Li X, Peng C, Wang P, Shen H, Weng Q, Xie H, Wang H, Jiang B, Zhou K, Liang N, He Y, Dai Y, Fang Z, Liang S, Zhang Y, Morse A, Zhu L. Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2025 Jun 27;389:e084418. doi: 10.1136/bmj-2025-084418.

  PMID: 40578851 DERIVED

• 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

Interventions

Vaginal Creams, Foams, and Jellies; Dosage Forms; Pessaries

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies; Technology, Pharmaceutical; Investigative Techniques; Surgical Equipment

Central Study Contacts

Lan Zhu

CONTACT

+86-69156874; zhu_julie@vip.sina.com

Ying Zhou

CONTACT

+86-69156204; shellypumch@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general gynecology Center

Model Details: Two-arm,Randomized, Double- Blind, Placebo Controlled, Clinical Trial

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: May 24, 2020
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: starting 6 months after publication