Annovera Use for 1 Year Without Breaks for Heavy Periods
Annovera is FDA-approved for use in 21-day in/7-day out cycles for up to 13 cycles (1 year total), but continuous use without the 7-day breaks is not an approved regimen and lacks safety data. 1, 2
Understanding Annovera's Approved Use
Annovera (segesterone acetate and ethinyl estradiol vaginal system) is designed to be inserted for 21 consecutive days, then removed for 7 days to allow withdrawal bleeding, with the same ring reused for up to 13 cycles (1 year total). 1, 2
The ring releases segesterone acetate at 150 mcg/day and ethinyl estradiol at 13 mcg/day during the 21-day insertion period. 2
There is no published evidence supporting continuous use without the 7-day removal intervals, which differs fundamentally from the FDA-approved regimen. 1, 2
Why Continuous Use Is Problematic
The FDA approval and all clinical trials used the 21-day in/7-day out regimen—continuous use represents off-label use without safety or efficacy data. 2
Annovera already showed higher-than-expected venous thromboembolism (VTE) rates in clinical trials, prompting the FDA to require postmarketing studies to determine the true incidence of this adverse effect. 2
Eliminating the hormone-free interval could theoretically increase VTE risk further, as continuous estrogen exposure without breaks has not been studied with this specific device. 2
The ring's hormone release rates are calibrated for 21-day cycles; continuous use for 365 days would exceed the studied duration and may alter drug delivery characteristics. 1
Evidence-Based Alternatives for Heavy Menstrual Bleeding
For managing heavy periods, the levonorgestrel-releasing intrauterine system (LNG-IUS) is the most effective first-line medical therapy, reducing menstrual blood loss by 71-95%. 3, 4
First-Line Options:
LNG-IUS: Most effective treatment, reducing menstrual blood loss by 71-95%, comparable to endometrial ablation. 3, 4
Combined oral contraceptives (COCs): Monophasic pills with 30-35 μg ethinyl estradiol are recommended as first-line for adolescents and can be used in extended regimens (3-4 months of active pills followed by 4-7 day hormone-free interval). 3
Standard vaginal ring (NuvaRing): Can be used in extended regimens by replacing monthly rather than using the 21/7 schedule, as rings contain sufficient medication for up to 35 days. 5
Extended Regimen Management:
For breakthrough bleeding with extended CHC regimens, a 3-4 day hormone-free interval can be taken, but not during the first 21 days of use and not more than once per month to maintain contraceptive effectiveness. 5, 3
Unscheduled bleeding is common during the first 3-6 months of extended use but generally decreases with continued use. 5
NSAIDs for 5-7 days can be added to manage breakthrough bleeding. 5, 3
Second-Line Options:
Tranexamic acid: Effective for heavy bleeding but contraindicated in women with active thromboembolic disease or history of thrombosis. 5, 4
Depot medroxyprogesterone acetate (DMPA): Can induce amenorrhea after ≥1 year of use; NSAIDs for 5-7 days can manage breakthrough bleeding. 3
Critical Safety Considerations
Before initiating any extended hormonal regimen, rule out underlying conditions including pregnancy, sexually transmitted infections, thyroid disorders, or pathologic uterine conditions (polyps, fibroids). 5, 3
VTE risk increases 3-4 fold with combined hormonal contraceptives (up to 4 per 10,000 woman-years), and Annovera showed higher-than-expected rates in trials. 3, 2
Blood pressure monitoring is recommended at follow-up visits for patients using combined hormonal contraceptives. 3
Practical Recommendation
If the goal is continuous contraception with amenorrhea to manage heavy periods, switch to a LNG-IUS or use extended-regimen COCs (3-4 months active pills with brief hormone-free intervals) rather than attempting continuous Annovera use. 3, 4 These approaches have established safety profiles and strong evidence for reducing menstrual blood loss, whereas continuous Annovera use lacks any supporting data and carries unknown risks given the device's already elevated VTE signal. 2