Divigel® offers plant-based bioidentical estradiol in three dosing options for individualized treatment of vasomotor symptoms due to menopause:

Divigel® is the only estrogen therapy to offer the lowest FDA approved dose at 0.25 mg/day.

0.25mg 0.5mg 1mg

Divigel® is effective at reducing hot flashes2

Divigel® reduced the frequency of vasomotor symptoms2
Chart 1
Severity Chart

This was a 12-week, randomized, double-blind, placebo-controlled clinical trial of 488 post-menopausal women who received 1 mg, 0.5 mg, or 0.25 mg of Divigel® or placebo gel daily.2 98.6% [481/488] of all patients had severe vasomotor symptoms at baseline.2

0.5mg/day is not statistically significant from placebo until week 4 and beyond, and week 5 and beyond 0.25/day.

  • At the highest dose (1 mg/day) Divigel® eliminated nearly 9 out of 10 daily hot flashes by week 12.2
  • As early as 2 weeks, Divigel® (1 mg/day) was shown to reduce the frequency of hot flashes by nearly HALF.2
  • At the lowest dose (0.25 mg/day) Divigel® eliminated about 70% of daily hot flashes by 12 weeks.2
Divigel® reduced the severity of vasomotor symptoms in 12 weeks2
Chart 2

This was a 12-week, randomized, double-blind, placebo-controlled clinical trial of 488 post-menopausal women who had severe host flash symptoms

Data remain significant from placebo at week 12.

  • Divigel® reduced the severity of hot flashes by 67% at 12 Weeks (1 mg/day).2
  • All dose strengths have been proven to reduce the severity of hot flashes.2
  • 0.25 mg is not statistically significant until 7 weeks.2
  • On Divigel® your patients may not only experience fewer hot flashes and night sweats over time but those symptoms may also be less severe.2
Divigel® provides 24-hour estradiol coverage at all dose strengths3

MEAN SERUM ESTRADIOL CONCENTRATION [PG/ML]

Chart 1
  • Divigel® sustained serum concentrations of estradiol over 24 hours.
MEAN SERUM ESTRADIOL CONCENTRATIONS [Cavg]*3
1 mg/day
0.5 mg/day
0.25 mg/day
30.5 pg/mL
21 pg/mL
9.8 pg/mL*
*Day 14 following multiple daily doses of Divigel® 0.1% [values uncorrected for baseline].
  • Divigel® offers 3 dosing options for individualized treatment.
  • Only Divigel® offers the lowest dose of topical estrogen get or spray available for hot flashes (0.25mg/day estradiol)1

DELIVERED THROUGH THE SKIN

Although the clinical significance has not been determined, estradiol from Divigel® does not undergo first pass metabolism.4,5

 

DIVIGEL® TOPICAL GEL

ORAL TREATMENTS

REFERENCES
1. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm accessed April 27, 2018.
2. Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
3. Divigel® [package insert]. Vertical Pharmaceuticals, LLC; 2018.
4. Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause. Endocr Pract. 2011;17(suppl 6):1-25.
5. Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric. 2004;7(4):347-356.

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