Placebo (n=73)13
0.75mg Oestrogel (n=75)13
1.5mg Oestrogel (n=73)14
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Oestrogel® (estradiol 0.06% w/w) efficacy
Empower her to own her menopause
Oestrogel® (estradiol 0.06% w/w) efficacy
Oestrogel is a hormone replacement therapy (HRT) indicated for oestrogen deficiency symptoms in postmenopausal women and prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.2
The experience treating women older than 65 years is limited.2
The experience treating women older than 65 years is limited.2
Oestrogel is proven to reduce hot flushes3
Oestrogel significantly reduces the mean daily frequency of moderate-to-severe hot flushes at Week 12 compared to placebo (p<0.05).2
Study design (Archer 2003)3
A 12-week, multicentre, double-blind, randomised, placebo-controlled study of the effects of Oestrogel in 221 postmenopausal women to assess the effects of a percutaneous 17B-estradiol gel on vasomotor symptoms (VMS) compared to placebo.
Inclusion criteria3
Participants were assigned to receive either 1.25g or 2.5g of percutaneous 17β-estradiol gel or placebo, applied once daily over a 12-week period to evaluate efficacy and tolerability.
Primary endpoint3
The mean change from baseline to Week 12 in the daily frequency of moderate-to-severe hot flushes.
Secondary endpoints3
Frequency and severity of all VMS and vaginal maturation index.
In Week 12, the mean percent decrease from baseline in the frequency of moderate-to-severe hot flushes was 82% estradiol gel 2.5g and 57% with placebo gel3
The mean number of moderate-to-severe hot flushes at 12 weeks was 2.0 in the 2.5g group (n=73), 2.8 in the 1.25g group (n=75) and 5.2 in the placebo group (n=73).3
At Week 12, Oestrogel had a significant (p=<0.05) reduction of hot flush severity when compared to placebo3
The mean change from baseline severity of moderate-to-severe hot flushes at 12 weeks was -1.0 (43% decrease) in the 2.5g group (n=71).3
Safety data3
Adverse events (>10%) reported over a 12-week period
| Adverse event | Placebo (n=73) | 0.75mg Oestrogel (n=75) | 1.5mg Oestrogel (n=73) |
|---|---|---|---|
| Headache | 13 | 13 | 14 |
| Nausea | 3 | 4 | 9 |
| Breast pain | 7 | 8 | 8 |
| Infection | 5 | 12 | 5 |
| Pain | 8 | 5 | 4 |
| Vaginitis | 3 | 8 | 1 |
Adverse event
Headache
Nausea
Placebo (n=73)3
0.75mg Oestrogel (n=75)4
1.5mg Oestrogel (n=73)9
Breast pain
Placebo (n=73)7
0.75mg Oestrogel (n=75)8
1.5mg Oestrogel (n=73)8
Infection
Placebo (n=73)5
0.75mg Oestrogel (n=75)12
1.5mg Oestrogel (n=73)5
Pain
Placebo (n=73)8
0.75mg Oestrogel (n=75)5
1.5mg Oestrogel (n=73)4
Vaginitis
Placebo (n=73)3
0.75mg Oestrogel (n=75)8
1.5mg Oestrogel (n=73)1
The most common adverse events were headache (18.1%), breast pain (10.4%), infection (10.0%), pain (7.7%), nausea (7.2%), rash (5.4%) and vaginitis (5.4%).3
Oestrogel was effective and generally well tolerated for alleviating moderate-to-severe hot flushes in postmenopausal women.3
Preference satisfaction data for Oestrogel patients4
In a survey (organised and funded by Besins Healthcare UK) we asked Oestrogel patients (N=156) how satisfied they were with the following features of the Oestrogel pump-pack:4
were very/fairly satisfied with ease of use
were very/fairly satisfied with how well Oestrogel fits into their daily life
were very/fairly satisfied with how effective Oestrogel is in reducing their menopause symptoms
Abbreviations
HRT, hormone replacement therapy; VMS, vasomotor symptoms.
References
- Data on file. REF-OES-00473 July 2025
- Oestrogel (estradiol) Pump-Pack 750 micrograms/actuation gel Summary of Product Characteristics
https://www.medicines.org.uk/emc/product/353/smpc.Accessed June 2026 - Archer DF, et al. Menopause 2003;10(6):516–521.
- Data on file. REF-OES-00454 May 2025
June 2026 | MAT-PROMO-OES-0309
Adverse event reporting
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: drugsafety@besins-healthcare.com
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