Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

NCT02460302 | Withdrawn Phase 2 DMC

• 1 other identifier: 12-0306-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local estrogens have been used to treat atrophic vaginitis Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been studied in other populations including as a fertility medication in pregnant women. There is a significant group of women who cannot use, choose not to use, or do not respond to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the treatment options for patients with symptoms of vaginal atrophy.

Conditions

Atrophic Vaginitis; Menopause; Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Perceived Improvement in most bothersome vulvovaginal symptom

  Improvement in patient-identified most bothersome symptom (vaginal dryness, itching, soreness, pain with sexual activity)

  12 weeks

Secondary Outcomes (1)

• Change in physician-assigned vaginal health index score based on a detailed rating scale

  12 weeks

Other Outcomes (2)

• Change in vaginal maturation index value

  12 weeks

• Change in vaginal pH values

  12 weeks

Study Arms (2)

Vaginal Progesterone

EXPERIMENTAL

In the experimental arm, the participants will be randomized (1:1 allocation) to receive a vaginal progesterone suppository (100mg) as the intervention. Participants will be instructed to insert the vaginal suppository into the vagina, as high as is comfortable for the patient. They are to insert the drug three days per week, on Monday, Wednesday and Fridays, preferably at bedtime. Patients will record the use of their medications. This will be done for the study period of 12 weeks.

Drug: Vaginal progesterone

Placebo Comparator

PLACEBO COMPARATOR

In the placebo arm, the participants will be randomized (1:1 allocation) to receive a vaginal suppository (100mg) containing hard fat without any active hormonal ingredient as the intervention. Participants will be instructed to insert the vaginal suppository into the vagina, as high as is comfortable for the patient. They are to insert the placebo three days per week, on Monday, Wednesday and Fridays, preferably at bedtime. Patients will record the use of their medications. This will be done for the study period of 12 weeks.

Drug: Placebo

Interventions

Vaginal progesterone DRUG

Micronized vaginal progesterone 100mg inserted vaginally

Also known as: Oripro

Vaginal Progesterone

Placebo DRUG

Placebo suppository inserted vaginally

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 45, unless the patient has had a bilateral oophorectomy
• Amenorrheic for greater than one year and/or FSH \> 40IU/mL
• Women who have had a bilateral oophorectomy will be eligible at any age
• Patients must have greater than or equal to two urogenital atrophy symptoms:
• vaginal dryness
• vaginal irritation
• vaginal soreness
• dyspareunia

You may not qualify if:

• Age less than 45
• Systemic or local hormone replacement therapy use within three months of entry into study
• Known or suspected history of breast cancer
• Hormone dependent tumor
• Genital bleeding of unknown cause
• Current vaginal infection requiring treatment
• Known allergy to test constituents
• Serious disease or chronic condition that could interfere with compliance
• Active thrombophlebitis, or history of a hormone-associated thrombophlebitis
• Kidney disease
• Liver dysfunction or disease
• High LDL levels
• Women who have used systemic or local hormone replacement therapy will be ineligible for participation in the study. If these women wish to participate, they must undergo a washout period. This would be as follows:
• eight weeks for oral estrogen and/or progestin therapy
• four weeks for transdermal or local vaginal hormone therapies

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

  PMID: 37619252 DERIVED

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Wendy L Wolfman, MD, FRCSC

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynaecology, University of Toronto

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (1)