Bijuva for Menopause
Bijuva (estradiol 1 mg/progesterone 100 mg) is an FDA-approved, effective treatment for moderate to severe vasomotor symptoms in postmenopausal women with an intact uterus, offering a rigorously studied bioidentical hormone option that significantly reduces hot flash frequency and severity while providing endometrial protection. 1, 2, 3
What Bijuva Is and How It Works
Bijuva is a single-capsule combination of bioidentical 17β-estradiol and progesterone, taken once daily, specifically designed for continuous use in women who still have a uterus 2, 3
The FDA-approved dose is 1 mg estradiol/100 mg progesterone, which demonstrated superior efficacy in clinical trials 2, 3
This represents the first FDA-approved bioidentical combination product for menopausal symptoms, addressing concerns about unregulated compounded bioidentical hormones that lack safety and efficacy data 4, 3
Clinical Efficacy
In the pivotal REPLENISH trial, Bijuva significantly reduced both the frequency and severity of vasomotor symptoms at 4 and 12 weeks compared to placebo, meeting co-primary endpoints 2
All tested doses met the primary endpoint of endometrial safety with no cases of endometrial hyperplasia observed over 52 weeks, confirming adequate endometrial protection from the progesterone component 2
Amenorrhea rates were high and improved over time, and quality of life measures (including sleep) significantly improved with treatment 2
Menopausal hormone therapy remains the most effective treatment for vasomotor symptoms, with efficacy superior to all non-hormonal alternatives 4, 5, 6, 7
Who Should Use Bijuva
Ideal candidates include:
Postmenopausal women under age 60 or within 10 years of their final menstrual period with moderate to severe vasomotor symptoms who have an intact uterus 6, 7
Women seeking a rigorously studied bioidentical hormone option as an alternative to synthetic hormones or unregulated compounded products 3
Symptomatic women in whom benefits outweigh risks after careful assessment of medical history and cardiovascular/breast cancer risk 6
Absolute Contraindications
Do not use Bijuva in women with: 4, 1
- History of hormone-dependent cancers (breast, endometrial)
- Undiagnosed abnormal vaginal bleeding
- Active or recent thromboembolic events (stroke, DVT, PE)
- Active liver disease
- Current pregnancy or breastfeeding
- History of stroke or heart attack in the past year
Use With Caution In
- Women with coronary heart disease or hypertension 4
- Current smokers 4
- Women with increased genetic cancer risk 4
Treatment Algorithm
Step 1: Start with lifestyle modifications for all women—weight loss if BMI elevated, smoking cessation, limiting alcohol if it triggers symptoms, regular physical activity 4, 5
Step 2: For women with moderate to severe symptoms not controlled by lifestyle changes, initiate Bijuva 1 mg/100 mg once daily 1, 2, 3
Step 3: Use the lowest effective dose for the shortest duration necessary, with regular reassessment every 3-6 months about continued need 4, 1
Step 4: Preferably limit duration to less than 5 years to minimize long-term risks, though this should be balanced against symptom severity and quality of life 4, 5
Safety Profile
Bijuva was well tolerated with no clinically significant impact on vital signs, metabolic parameters, coagulation studies, or breast safety in clinical trials 2
The progesterone component (micronized progesterone) may be preferred over synthetic progestins like medroxyprogesterone acetate due to lower rates of venous thromboembolism and potentially lower breast cancer risk 4
Oral estradiol carries risks of stroke, venous thromboembolism, and breast cancer (particularly with prolonged use beyond 5 years), though absolute risks remain low in appropriate candidates 4
Key Advantages Over Alternatives
Provides both symptom relief and endometrial protection in a single capsule, eliminating need for separate estrogen and progestin products 2, 3
Uses bioidentical hormones with rigorous FDA oversight, unlike custom-compounded bioidentical hormones which lack supporting safety and efficacy data 4, 3
Demonstrated superior efficacy compared to non-hormonal options (SSRIs, SNRIs, gabapentin, clonidine) which are less effective alternatives 4, 5, 7
Common Pitfalls to Avoid
Failing to screen for contraindications, particularly undiagnosed vaginal bleeding or history of hormone-dependent cancers 4, 1
Using in women over age 60 or more than 10 years from menopause onset, when risks outweigh benefits 6, 7
Continuing therapy indefinitely without regular reassessment of ongoing need and risk-benefit balance 4, 1
Prescribing for women without a uterus, who should receive estrogen-only therapy instead 4, 1