Methods of contraception using nomegestrol acetate and estradiol
Inventors
Assignees
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Publication Number
US-12616703-B2
Publication Date
2026-05-05
Expiration Date
Abstract
Provided are methods of contraception using as a first line combined oral contraceptive (COC), a COC composition comprising nomegestrol acetate (NOMAC) and estradiol or an ester thereof. Said COC compositions are associated with a lower risk of venous thromboembolism (VTE) as compared to other CHCs. The compositions may also be used in methods of treatment in women having conditions linked to menstruation and/or fertility.
Core Innovation
The invention relates to a method of contraception that identifies a woman desirous of contraception as suitable for receiving a combined hormonal contraceptive (CHC). The method selects a combined oral contraceptive (COC) composition comprising nomegestrol acetate and estradiol, or an ester thereof, identified as a CHC associated with lowest risk of venous thromboembolism (VTE), and provides the selected COC composition to the woman desirous of contraception.
The method specifies that the woman desirous of contraception achieves a reduced VTE risk by at least about 10% compared to a reference risk of VTE for a COC containing levonorgestrel. The woman desirous of contraception is selected from particular categories, including a woman who has been pregnant within the past 3 months, a woman who has or has had cancer, a woman who is having or has had chemotherapy treatment, and a woman who has an increased genetic risk of VTE.
The document also ties the contraception approach to identifying women based on VTE-risk determination and risk-factor or comorbidity contexts, with a lowest VTE-risk basis used to support CHC selection. It further reports prospective, controlled cohort safety study outcomes for NOMAC-E2 versus a levonorgestrel comparator, including incidence and hazard ratio results for thromboembolic outcomes and no significant differences across several adverse outcomes.
Claims Coverage
The independent claim provides a patient-selection and CHC-selection workflow with 5 inventive features: identifying a woman suitable for a CHC, selecting a lowest-VTE-risk COC containing nomegestrol acetate and estradiol or an ester thereof, providing it to the woman, restricting eligibility to specified women, and achieving at least about 10% VTE-risk reduction versus a levonorgestrel reference risk.
Identifying a woman suitable for a CHC
The method identifies a woman desirous of contraception as suitable for receiving a combined hormonal contraceptive (CHC).
Selecting a lowest-VTE-risk COC comprising NOMAC and estradiol
The method selects a CHC associated with lowest risk of venous thromboembolism (VTE), wherein the selected CHC is a combined oral contraceptive (COC) composition comprising nomegestrol acetate and estradiol or an ester thereof.
Providing the selected COC composition to the woman
The method provides the COC composition comprising nomegestrol acetate and estradiol or an ester thereof to the woman desirous of contraception.
Restricting eligibility to specified women
The method defines that the woman desirous of contraception is selected from at least one of: a woman who has been pregnant within the past 3 months, a woman who has or has had cancer, a woman who is having or has had chemotherapy treatment, and a woman who has an increased genetic risk of VTE.
Achieving at least about 10% reduced VTE risk versus levonorgestrel reference
The method requires that the woman desirous of contraception achieves a risk of VTE that is reduced by at least about 10% compared to a reference risk of VTE for a COC containing levonorgestrel.
Overall, the claim coverage focuses on selecting and providing a COC comprising nomegestrol acetate and estradiol or an ester thereof that is identified as having lowest VTE risk, restricting the eligible woman to specified categories, and ensuring at least about 10% VTE-risk reduction versus a levonorgestrel reference risk.
Stated Advantages
Reduced VTE risk by at least about 10% compared to a reference risk of VTE for a COC containing levonorgestrel.
Lower unintended pregnancy incidence is reported for NOMAC-E2 versus the comparator.
No significant differences in several reported adverse outcomes including arterial thromboembolism, cholelithiasis, inflammatory bowel disease, general hepatobiliary disorders, depressive disorders, and weight.
Documented Applications
Contraception using a combined oral contraceptive (COC) comprising nomegestrol acetate and estradiol or an ester thereof, with CHC selection based on lowest VTE risk and VTE-risk assessment or patient selection concepts.
Treatment of menstruation and fertility-linked conditions via CHC selection based on lowest VTE risk, including painful menstrual bleeding, heavy or prolonged bleeding, acne, ovarian cysts, PCOS, PMS, endometriosis, and PMDD.
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