Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire. Pilot study.

Instituto Palacios de Salud y Medicina de la Mujer0 sites29 target enrollmentMarch 28, 2019

Overview

Registry

who.int

Start Date

March 28, 2019

End Date

August 31, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

Female

Sponsor

Instituto Palacios de Salud y Medicina de la Mujer

•1\. Healthy, postmenopausal women (no natural menses for at least 1 year) aged \= 45 and \= 65\. Hysterectomized patients should have an FSH level above 40 IU.
•2\. Stable partner, living together for at least 15 days a month and being sexually available.
•3\. Risk of sexual dysfunction established at FSFI score\< 25\.83\.
•4\. Integrity of the vaginal mucosa (without lesions or bleeding).
•5\. Women willing to and capable of understanding and signing an informed consent after receiving an explanation on the nature of the whole study.
•6\. Consenting to participate in the study and signing the Informed Consent form.
•7\. No desire for pregnancy in the next 3 months.

•1\. Pregnant women or with suspected pregnancy.
•2\. Within 3 months following delivery or abortion.
•3\. Breastfeeding women.
•4\. Women with severe pain in sexual relationships (DMS\-V).
•5\. Non\-diagnosed abnormal genital bleeding or presence of vaginal lesions.
•6\. Women with symptoms of vaginal infection or signs of any other genital infection.
•7\. Women allergic or hypersensitive to the components of the study treatment.
•8\. Severe psychiatric disorder.
•9\. Use of any hormonal treatment with estrogens, progestogens, or estrogens and progestogens within 3 previous months prior to selection.
•10\. Use of any other drug or experimental device within 30 days prior to selection.