The ATC code is G03FA04 progesterone and oestrogen
Estradiol
The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.
Progesterone
The active ingredient, progesterone is a natural progestogen, that is chemically and biologically identical to endogenous human progesterone. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestogen greatly reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.
Clinical efficacy and safety
Bijuve (1 mg estradiol/100 mg progesterone) was evaluated in 726 postmenopausal women who participated in 1 phase 3 trial. Among these, 141 women were treated with 1 mg estradiol/100 mg progesterone and 135 received placebo. Endometrial safety was evaluated in 268 women for a period of 1 year.
Relief of oestrogen-deficiency symptoms and bleeding patterns.
Relief of menopausal symptoms was achieved during the first few weeks of treatment. In a 12-week study, 1mg estradiol/100 mg progesterone significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12.
In this study, amenorrhea was reported in 82.6% of the women who received 1mg estradiol/ 100 mg progesterone during months 10 to 12.
Bleeding and/or spotting
was reported in the 1mg estradiol/100 mg progesterone group by
30.1%
of women during the first 3 months of treatment and
by
17.4%
of women during months 10 to 12.
Endometrial safety
The effects of 1mg estradiol/100 mg progesterone (Bijuve) on the endometrium was assessed in the 52-week safety trial.
During the trial, assessments of endometrial biopsies taken at 12 months or at early trial discontinuation revealed 1 case of simple endometrial hyperplasia without atypia and no endometrial cancer in women who received Bijuve (1 mg estradiol/ 100 mg progesterone capsules (N=1/268, 0.37%; 2-sided 95% CI:1.83%).
Four (4) cases of disordered proliferative endometrium were also reported for BIJUVE 1 mg estradiol/ 100 mg progesterone) capsules.
⚠️ Warnings
Bijuve capsules no longer required should not be disposed via wastewater or the municipal sewage system. The hormonal active compounds in the capsule may have harmful effects if reaching the aquatic environment. The capsules should be returned to a pharmacy or disposed of in another safe way according to local requirements. These measures will help to protect the environment.
