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Abstract
Discussion Forum (0)
Introduction: Bothersome unscheduled bleeding is one of the main reasons cited for discontinuing a hormonal contraceptive method. Here, we present unscheduled bleeding data from a phase 3 trial with a novel combined oral contraceptive (COC) containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Introduction: Bothersome unscheduled bleeding is one of the main reasons cited for discontinuing a hormonal contraceptive method. Here, we present unscheduled bleeding data from a phase 3 trial with a novel combined oral contraceptive (COC) containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Unscheduled bleeding and/or spotting episodes in a Phase 3 Clinical Trial of Estetrol/Drospirenone
Dr. Mitchell D Creinin
Affiliations:
University of California, Davis
University of California, Davis
Abstract
Discussion Forum (0)
Introduction: Bothersome unscheduled bleeding is one of the main reasons cited for discontinuing a hormonal contraceptive method. Here, we present unscheduled bleeding data from a phase 3 trial with a novel combined oral contraceptive (COC) containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Introduction: Bothersome unscheduled bleeding is one of the main reasons cited for discontinuing a hormonal contraceptive method. Here, we present unscheduled bleeding data from a phase 3 trial with a novel combined oral contraceptive (COC) containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
Methods: This multicenter, open-label, IRB-approved study enrolled 2148 US and Canadian participants (16-50 years, body mass index (BMI) ≤35 kg/m2) of whom 1864 were 16-35 years. Subjects recorded bleeding patterns in daily diaries over 13 consecutive cycles. Unscheduled bleeding and/or spotting episodes were analyzed based on age, BMI, and starters/switchers of hormonal contraceptives.
Results: Unscheduled bleeding and/or spotting episodes decreased in 16-25-years (n=839) and 26-35-years (n=835) old participants from cycle 1 (30% in both groups) to cycle 2 (21% and 23%, respectively) and was less than 20% from cycle 5, except for cycle 7 (21%) among 26-35-years old subjects. No clinically important differences were observed in subjects with BMI < 30 kg/m2 (n=1,298) and BMI ≥30 kg/m2 (n=376) (30% and 31% during the first cycle and subsequently 14-18% and 18-24%, respectively). Unscheduled bleeding and/or spotting decreased in starters (n=973) from 35% in cycle 1 to 22% in cycle 5 and ranged between 17-21% thereafter. Switchers (n=701) unscheduled bleeding and/or spotting episodes decreased from 23% in cycle 1 to 20 % in cycle 5 and ranged between 12-17% thereafter.
Conclusion/Implications: In US and Canadian study participants using an E4/DRSP-containing COC, unscheduled bleeding/spotting episodes decreased over time ( < 20% of participants after cycle 5), when analyzed by age, BMI and contraceptive history.
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