Lead Sponsor

Angelica Lindén Hirschberg

Age

40 - 80 years

Sex

FEMALE

Healthy Volunteers

No

•Postmenopausal women (non-hysterectomized or hysterectomized) must satisfy either: a) No menses for at least one year for non-hysterectomized women, or b) Follicle stimulating hormone (FSH) levels \>40 IU/L
•Women who have self-identified at screening and baseline (Day 1) as experiencing moderate to severe dyspareunia, using VASQ questionnaire (section 1)
•Between 40 and 80 years of age
•Body mass index (BMI) 19-35
•Women having a vaginal pH above 5 at screening and baseline (Day 1)
•Women who currently have intercourse or other sexual activity, at least once a month, with a partner
•Normal mammogram within 12 months (of Day 1)
•A normal PAP smear (which includes inflammatory changes) within the last 12 months (of Day 1) for both non-hysterectomized and hysterectomized women.
•Understands Swedish and is willing to participate in the study and sign an informed consent

•Undiagnosed abnormal vaginal bleeding
•Previous diagnosis of cancer, except skin cancer (non-melanoma)
•Lichen Sclerosis and other pathological conditions in vulva and/or vagina
•Active or history of thromboembolic disease
•Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
•Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy in the 8 weeks prior to baseline assessments (screening visit)
•Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products in the 4 weeks prior to baseline assessments (screening visit)
•Use of testosterone or other anabolic steroid within 6 months prior to screening visit
•Natural oral estrogenic products in the 4 weeks prior to baseline assessments
•Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance
•The administration of any investigational drug within 30 days of screening visit

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