Divigel® offers an estradiol gel in four dosing options for individualized treatment of moderate to severe vasomotor symptoms due to menopause:

Divigel® is the only estrogen therapy to offer the lowest FDA approved transdermal estradiol gel or spray available at 0.25 mg/day.1

0.25mg 0.5mg 0.75mg 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
  • Efficacy studies were not required for approval of the 0.75 mg dose. Divigel® demonstrated linear and approximately dose-proportional estradiol pharmacokinetics at steady state levels following once daily dosing to the skin of either the right or left upper thigh.3
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
  • Efficacy studies were not required for approval of the 0.75 mg dose. Divigel® demonstrated linear and approximately dose-proportional estradiol pharmacokinetics at steady state levels following once daily dosing to the skin of either the right or left upper thigh.3
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
  • Efficacy studies were not required for approval of the 0.75 mg dose. Divigel® demonstrated linear and approximately dose- proportional estradiol pharmacokinetics at steady state levels following once daily dosing to the skin of either the right or left upper thigh.3

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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