vaginal atrophy. Postmenopausal Atrophic Vaginitis
Conditions
Interventions
Intervention 1: Intervention 2: 12-week treatment period. Conjugated estrogen vaginal cream once daily for 2 weeks? followed by twice weekly administration for a further 10 weeks as a maintenance ther
Treatment - Drugs
Intervention 2: 12-week treatment period. Conjugated estrogen vaginal cream once daily for 2 weeks? followed by twice weekly administration for a further 10 weeks as a maintenance therapy
Intervention1: 12-week treatment period. Vitamin E vaginal suppositories once daily for 2 weeks ? followed by twice weekly administration for a further 10 weeks as a maintenance therapy.
Sponsors
Mashhad Universityof Medical Sciences
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age between 40-65 years old; amenorrhea for at least 12 months, or 6 months after the last menstrual them with FSH> 40; having a normal Pap smear within the past 3 years, or more than 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; clinical atrophy of the vagina through a set of criteria that includes: PH vagina> 5 and earn a score of 65 or higher (based on a visual analogue scale, VAS) for most bothersome symptoms (MBS) and superficial cells equal or less than 5% and at least two symptoms of Descriptive Assessment Table of Vaginal Mucosa. Exclusion criteria: existing breast or endometrial cancer or suspicion thereof, genital abnormalities; abnormal vaginal bleeding; cardiovascular disease (including coronary heart disease; cerebrovascular disease; thromboembolic disorders); active liver or gallbladder disease; diabetes and blood pressure-lowering drugs; vaginal infection; allergy to estrogen and vitamin E; hormone use during the 8 weeks before the study; the use of 40 to 60 grams phytoestrogens during the day; use of stimuli that can cause chronic itching in the vagina; useing less than 70% of the total number of drug (less than 24 times during the treatment period
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of vaginal atrophy. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Description of the vaginal mucosa? vaginal maturation index, the most bothersome symptom of vaginal and vaginal pH. | — |
Secondary
| Measure | Time frame |
|---|---|
| Superficial cells in the vagina. Timepoint: Befor the intervention? 4? 8 and 12 weeks after intervention. Method of measurement: Vaginal maturation index. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAazam Prnan Emamverdikhan
Mashhad University of Medical Sciences
Outcome results
None listed