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Evaluation of the Effect of Hormone-Free Creams Compare to Estrogenic Creams in Postmenopausal Women with Vulvovaginal Atrophy

Evaluation of the Effect of Hormone-Free Creams Compare to Estrogenic Creams in Postmenopausal Women with Vulvovaginal Atrophy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230408057852N1
Enrollment
180
Registered
2023-09-30
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Postmenopausal atrophic vaginitis. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: Intervention group: using of Hormone-free vaginal creams for 8 weeks with an applicator ( Paraffin , hexyl laurate , essence , Aloe Vera) . The first 2 weeks every night in the releva

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal women who have been passed at least 1 year since their last period stopped. The one who have at least one of the vulvovaginal atrophy symptoms such as dryness , burning , itching vulve and vagina and dysparonia Having satisfaction for using each types of medications which offers randomly

Exclusion criteria

Exclusion criteria: Having contraindications of Estrogenic medications such as coronary artery disease , thromboemboli , previous thrombophlebitis , malignancies which are sensitive to Estrogenic-Hormone receptors like breast cancer , endometr or ovaries cancers. using hormonal or vaginal medications in last 6 months using other vaginal products or hormonal tablets infections or vulvovginal lesions such as psoriasis , lichen planus , lichen sclerosis abnormal pap smear results

Design outcomes

Primary

MeasureTime frame
Vulvovaginal dryness. Timepoint: Before intervention and after 8 weeks of using according to the given prescription. Method of measurement: Subjective description by 0-4 ( 0: none , 1: mild , 2: moderate, 3: severe , 4 : very severe ).;Vulvovaginal burning. Timepoint: Before intervention and after 8 weeks of using according to the given prescription. Method of measurement: Subjective description by 0-4 ( 0: none , 1: mild , 2: moderate, 3: severe , 4 : very severe ).;Vulvovaginal itching. Timepoint: Before intervention and after 8 weeks of using according to the given prescription. Method of measurement: Subjective description by 0-4 ( 0: none , 1: mild , 2: moderate, 3: severe , 4 : very severe ).;Dyspareunia. Timepoint: Before intervention and after 8 weeks of using according to the given prescription. Method of measurement: Subjective description by 0-4 ( 0: none , 1: mild , 2: moderate, 3: severe , 4 : very severe ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoume Dadashaliha

Qazvin University of Medical Sciences

dadashaliham@yahoo.com+98 28 3335 2653

Outcome results

None listed

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