Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
Atrophic Vaginitis, Menopause, Vulvovaginal Atrophy
About this trial
This is an interventional treatment trial for Atrophic Vaginitis
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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.
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vaginal Progesterone
Placebo Comparator
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.
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.