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Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

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ClinicalTrials.gov Identifier: NCT02460302
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Wendy Wolfman, Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Atrophic Vaginitis Menopause Vulvovaginal Atrophy Drug: Vaginal progesterone Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy - a Double Blind Randomized Control Trial
Study Start Date : December 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: Vaginal Progesterone

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
Micronized vaginal progesterone 100mg inserted vaginally
Other Name: Oripro

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
Placebo suppository inserted vaginally




Primary Outcome Measures :
  1. Perceived Improvement in most bothersome vulvovaginal symptom [ Time Frame: 12 weeks ]
    Improvement in patient-identified most bothersome symptom (vaginal dryness, itching, soreness, pain with sexual activity)


Secondary Outcome Measures :
  1. Change in physician-assigned vaginal health index score based on a detailed rating scale [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Change in vaginal maturation index value [ Time Frame: 12 weeks ]
  2. Change in vaginal pH values [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age greater than or equal to 45, unless the patient has had a bilateral oophorectomy
  2. Amenorrheic for greater than one year and/or FSH > 40IU/mL
  3. Women who have had a bilateral oophorectomy will be eligible at any age
  4. Patients must have greater than or equal to two urogenital atrophy symptoms:

    • vaginal dryness
    • vaginal irritation
    • vaginal soreness
    • dyspareunia

Exclusion criteria:

  1. Age less than 45
  2. Systemic or local hormone replacement therapy use within three months of entry into study
  3. Known or suspected history of breast cancer
  4. Hormone dependent tumor
  5. Genital bleeding of unknown cause
  6. Current vaginal infection requiring treatment
  7. Known allergy to test constituents
  8. Serious disease or chronic condition that could interfere with compliance
  9. Active thrombophlebitis, or history of a hormone-associated thrombophlebitis
  10. Kidney disease
  11. Liver dysfunction or disease
  12. 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
  • eight weeks for progestin containing intrauterine system

Participants who are completing a washout period must complete the study questionnaire following the washout period.

Women will not be allowed to continue or commence use of non-hormonal therapies, including vaginal moisturizers, while they are in the study, However, we will allow the use of vaginal lubricants for sexual intercourse. Their use will be recorded on the patient questionnaire.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460302


Contacts
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Contact: Wendy L Wolfman, MD, FRCSC 416-586-4800 ext 4753 wwolfman@mtsinai.on.ca
Contact: Sheryl Hewko, RN 416-586-4800 ext 2977 sheryl.hewko@sinaihealthsystem.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Wendy Wolfman, MD, FRCSC    416-586-4800 ext 4753    wwolfman@mtsinai.on.ca   
Contact: Sheryl Hewko, RN, MSc    416-586-4800 ext 2977    sheryl.hewko@sinaihealthsystem.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Wendy L Wolfman, MD, FRCSC MOUNT SINAI HOSPITAL

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Responsible Party: Wendy Wolfman, Professor, Obstetrics and Gynaecology, University of Toronto, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02460302     History of Changes
Other Study ID Numbers: 12-0306-A
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Atrophy
Vaginitis
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs