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Laser vs vaginal conjugated estrogen in postmenopausal women

Evaluation of efficacy and safety of fractional co2 vs vaginal conjugated estrogen in postmenopausal women diagnosed as having vulvovaginal atrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017050433817N1
Enrollment
130
Registered
2017-06-08
Start date
2017-05-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vulvovaginal atrophy. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: The Fractional CO2 laser with Angela trademark( Fractional CO2 LASER MX-7000 smart pulse) , the treatment will be used for 3 Sessions and 4 weeks intervals. Intervention 2: topical con
n = 30) administered once daily for two weeks, then twice weekly for 8 weeks.
Treatment - Other
Treatment - Drugs
The Fractional CO2 laser with Angela trademark( Fractional CO2 LASER MX-7000 smart pulse) , the treatment will be used for 3 Sessions and 4 weeks intervals
topical conjugated estrogen (0.625 mg conjugated equine estrogens per 1 g vaginal cream

Sponsors

Ahvaz Jundishapur University of Medical Sciences, Research Development Unit0
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: (inclusion criteria: women's between 45-65 age suffering from Amenorrhea since 24 months; women's who diagnosed vaginally atrophy in clinical examination; women's who have sexual contract) (exclusion criteria: women who treated with systemic estrogen since 6 months ago; history of cancer; pathologic change in the cervical Pap smear; Renal or liver failure; women taking estrogen therapy in past history; Radiation therapy of the vagina; vulvovaginitis; History of psychotropic drug or opium use)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Vulvovaginal atrophy symptoms. Timepoint: at base line (day 0), 12 weeks post treatment. Method of measurement: visual analog scale measurement.

Secondary

MeasureTime frame
Adverse events. Timepoint: at baseline ( day 0), 12 weeks post treatment. Method of measurement: according to patient history.;Female Sexual Function Index. Timepoint: at baseline ( day 0), 12 weeks post treatment. Method of measurement: according to Female Sexual Function Index.;Sexual satisfaction. Timepoint: at baseline ( day 0), 12 weeks post treatment. Method of measurement: visual analog scale measurement.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHajatzadeh Saadat

Ahvaz Jundishapur University of Medical Sciences

info@ajums.ac.ir+98 61 3161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026