Zinc Containing Vaginal Topical " Suppository "
Condition: Genitourinary Syndrome of Menopause
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal
      symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary
      tract.

      The GSM includes not only genital symptoms (dryness, burning, and irritation) and sexual
      symptoms (lack of lubrication, discomfort or pain, and impaired function), but also urinary
      symptoms (urgency, dysuria, and recurrent urinary tract infections [UTI])
    

Detailed description: 
      The terms vulvovaginal atrophy and atrophic vaginitis were widely used until recently, but
      they have been considered to be inadequate for referring to the constellation of symptoms and
      signs associated with the genitourinary system after menopause.

      The term vulvovaginal atrophy mentions the vulva and vagina only, and these words are not
      used comfortably in general social discussion and in the media. The term atrophic vaginitis
      implies a state of inflammation or infection, which is not a primary component of menopausal
      changes. In addition, a limitation of the terms vulvovaginal atrophy and atrophic vaginitis
      is that they do not take into account the symptoms of the lower urinary tract, which are
      among the most important symptoms related to menopause.

      Vulvovaginal atrophy (VVA) is a prevalent condition affecting many postmenopausal women.1 Up
      to 40% of postmenopausal women develop symptoms of VVA.

      It is most often diagnosed by its symptoms, including vaginal dryness, burning, itching,
      vagina pain and dyspareunia. More recently these symptoms have been described as a syndrome:
      the genitourinary syndrome of menopause (GSM).

      This new term describes various menopausal symptoms and signs including not only genital
      symptoms but sexual (pain) and urinary symptoms (dysuria, urgency) as well.

      The pathophysiology of GSM/VVA can be explained by the decline in estrogen levels associated
      with diminished ovarian function and natural aging.

      Traditionally the treatment options for GSM/VVA was vaginal estrogen supplementation but many
      women are either unable to or are afraid to use hormones. There are several non-hormonal
      treatment modalities for the management of VVA related symptoms, especially for one of the
      most bothersome symptoms of vaginal dryness.

      The 2013 position statement of The North American Menopause Society indicates that the
      first-line therapies to alleviate symptoms of VVA should include non-hormonal vaginal
      lubricants and moisturizers as well as regular sexual activity.

      Although there are numerous vaginal moisturizers and lubricants are commercially available
      only a few of those have been tested in clinical trials.

      Previously the investigators showed the role of vaginal zinc supplementation on vaginal
      remodeling. The investigators showed that in human vaginal smooth muscle cells, zinc has a
      beneficial effect on the production of extracellular components produced by the muscle at 20
      μM zinc tissue level, thereby increasing the amount of elastin production.

      Earlier animal studies have shown that zinc plays an important role in the vaginal
      extracellular matrix (ECM) composition. When rats were kept on a zinc-lacking diet, the
      vaginal structure became similar to the menopausal vagina.With vaginal zinc replacement, the
      vaginal ECM could be regenerated with characteristics equivalent to juvenile rats .
    

Intervention name(s): Zinc
Intervention type(s): Drug
Intervention description(s): To test the effect of a novel zinc-containing vaginal topical on GSM/VVA symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment