Norethisterone 200mg/1ml solution for injection ampoules

Young women in sub-Saharan Africa are disproportionally affected by HIV infection and unintended pregnancies. However, hormonal contraceptive (HC) use may influence HIV risk through changes in genital tract microbiota and inflammatory cytokines. To investigate this, 130 HIV negative adolescent females aged 15-19 years were enrolled into a substudy of UChoose, an open-label randomized crossover study (NCT02404038), comparing acceptability and contraceptive product preference as a proxy for HIV prevention delivery methods. Participants were randomized to injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) or etonorgesterol/ethinyl estradiol combined contraceptive vaginal ring (CCVR) for 16 weeks, then crossed over to another HC for 16 weeks. Cervicovaginal samples were collected at baseline, crossover and exit for characterization of the microbiota and measurement of cytokine levels; primary endpoints were cervical T cell activation, vaginal microbial diversity and cytokine concentrations. Adolescents randomized to COCs had lower vaginal microbial diversity and relative abundance of HIV risk-associated taxa compared to Net-En or CCVR. Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En. This suggests that COC use may induce an optimal vaginal ecosystem by decreasing bacterial diversity and inflammatory taxa, while CCVR use is associated with genital inflammation.

Abstract licence: CC BY

Background Abnormal uterine bleeding (AUB) impacts women’s health and quality of life globally. Pharmacological management has prioritized hormonal agents such as norethisterone acetate; however, selective estrogen receptor modulators such as ormeloxifene have emerged as potential alternatives. Hence, this study aimed to assess and compare the effectiveness and safety of ormeloxifene and norethisterone acetate in women with AUB. Methodology This parallel, open-label, randomized controlled trial conducted at a tertiary center in central India included 60 women aged 21-47 years with AUB. Thirty participants each were assigned to ormeloxifene (60 mg twice weekly for 12 weeks, followed by once weekly for 12 weeks) or norethisterone acetate (5 mg twice daily for 21 days per cycle for six cycles). Primary endpoints included changes in pictorial blood loss assessment chart (PBAC) scores, hemoglobin concentration, and endometrial thickness (ET). Safety and the need for a hysterectomy were also assessed. Results Both groups were demographically comparable. The mean reduction in PBAC score at six months favored the ormeloxifene arm (-124.63 ± 14.65 vs. -103.73 ± 18.33, p < 0.001). The mean hemoglobin increase was significantly greater with ormeloxifene (2.26 ± 0.43 g/dL vs. 1.91 ± 0.66 g/dL, p = 0.019). ET reduction at six months was also superior in the ormeloxifene group (-8.90 ± 3.74 mm versus -6.20 ± 2.66 mm, p = 0.002). Side effects were infrequent and well-controlled, and surgical intervention was rarely required. Conclusions Ormeloxifene demonstrates superior efficacy in reducing menstrual blood loss, improving anemia, and suppressing endometrial proliferation in women with AUB compared to norethisterone acetate, with an acceptable safety profile.

Abstract licence: CC BY