In:
Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 133, No. 1 ( 2019-05), p. 7-7
Abstract:
A novel, ring-shaped, contraceptive vaginal system (CVS) containing segesterone acetate (SA), also known as Nestorone®, and ethinyl estradiol (EE) is designed to last 1 year (13 cycles), delivering an average of SA 0.15/EE 0.013 mg/day. Efficacy was evaluated in 2 multicenter, 1-year, open-label studies (one at 15 US sites; one at 5 US/7 international sites). METHODS: Women (18-40 yrs) used the CVS for 21 days/cycle followed by having it out for 7 days. Women were not to remove the CVS for 〉 2 hours during the 21 days of use. The primary efficacy outcome was the Pearl Index (PI) for women ≤35 years of age, excluding cycles with adjunctive contraception. Secondary outcomes included the PI for subgroups and intention-to-treat Kaplan-Meier life-table analyses. RESULTS: Of 2265 participants analyzed, 1303 (57.5%) completed. The primary PI was 2.98 (95% CI [2.13-4.06]). The PI was 2.10 (95% CI [1.37-3.06] ) in women who followed use instructions versus 5.89 (95% CI [3.46-9.27]) for women who documented removals 〉 2 hours ( P =0.0024). Significantly higher PIs were also observed in subgroups by age (18-19 yrs vs ≥36yrs), parity (≥1 vs 0), race (Black vs white), ethnicity (Hispanic vs non-Hispanic), and site (non-Europe vs Europe), but not by BMI. Life-table analyses revealed the CVS is 97.3% effective in preventing pregnancy. Pregnancies did not increase across cycles. CONCLUSION: The SA/EE CVS is an effective 1-year, procedure-free contraceptive controlled by women that can help address an unmet worldwide contraceptive need. Counseling to ensure correct use is essential for optimizing efficacy.
Type of Medium:
Online Resource
ISSN:
0029-7844
DOI:
10.1097/01.AOG.0000559088.01101.9a
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2019
detail.hit.zdb_id:
207330-4
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