Estetrol‐Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia
Objectives To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Design Multicenter, open‐label, phase 3 trial. Setting Sixty‐nine sites in Europe and Russia. Population Sexually active women ag...
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| Vydané v: | BJOG : an international journal of obstetrics and gynaecology Ročník 129; číslo 1; s. 63 - 71 |
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| Hlavní autori: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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England
Wiley Subscription Services, Inc
01.01.2022
John Wiley and Sons Inc |
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| ISSN: | 1470-0328, 1471-0528, 1471-0528 |
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| Abstract | Objectives
To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.
Design
Multicenter, open‐label, phase 3 trial.
Setting
Sixty‐nine sites in Europe and Russia.
Population
Sexually active women aged 18–50 years with regular menstrual cycles and body mass index ≤35 kg/m2.
Methods
E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.
Main outcome measures
Pearl Index (PI) for women 18–35 years (overall and method‐failure), bleeding pattern and AEs.
Results
A total of 1553 women aged 18–50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman‐years (95% CI 0.15–1.11); method failure PI was 0.29 pregnancies/100 woman‐years (95% CI 0.06–0.83). Scheduled bleeding/spotting occurred in 91.9–94.4% of women over Cycles 1 to 12 and lasted a median of 4–5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment‐related serious AE was reported, a lower extremity venous thromboembolism. One‐hundred and forty‐one (9.1%) women discontinued study participation because of treatment‐related adverse events.
Conclusion
E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.
Tweetable
A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.
Tweetable
A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.
This article includes Author Insights, a video available at: https://vimeo.com/bjog/authorinsights16840 |
|---|---|
| AbstractList | Objectives
To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.
Design
Multicenter, open‐label, phase 3 trial.
Setting
Sixty‐nine sites in Europe and Russia.
Population
Sexually active women aged 18–50 years with regular menstrual cycles and body mass index ≤35 kg/m2.
Methods
E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.
Main outcome measures
Pearl Index (PI) for women 18–35 years (overall and method‐failure), bleeding pattern and AEs.
Results
A total of 1553 women aged 18–50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman‐years (95% CI 0.15–1.11); method failure PI was 0.29 pregnancies/100 woman‐years (95% CI 0.06–0.83). Scheduled bleeding/spotting occurred in 91.9–94.4% of women over Cycles 1 to 12 and lasted a median of 4–5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment‐related serious AE was reported, a lower extremity venous thromboembolism. One‐hundred and forty‐one (9.1%) women discontinued study participation because of treatment‐related adverse events.
Conclusion
E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.
Tweetable
A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.
Tweetable
A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.
This article includes Author Insights, a video available at: https://vimeo.com/bjog/authorinsights16840 ObjectivesTo assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.DesignMulticenter, open‐label, phase 3 trial.SettingSixty‐nine sites in Europe and Russia.PopulationSexually active women aged 18–50 years with regular menstrual cycles and body mass index ≤35 kg/m2.MethodsE4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.Main outcome measuresPearl Index (PI) for women 18–35 years (overall and method‐failure), bleeding pattern and AEs.ResultsA total of 1553 women aged 18–50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman‐years (95% CI 0.15–1.11); method failure PI was 0.29 pregnancies/100 woman‐years (95% CI 0.06–0.83). Scheduled bleeding/spotting occurred in 91.9–94.4% of women over Cycles 1 to 12 and lasted a median of 4–5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment‐related serious AE was reported, a lower extremity venous thromboembolism. One‐hundred and forty‐one (9.1%) women discontinued study participation because of treatment‐related adverse events.ConclusionE4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.Tweetable abstractA phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.OBJECTIVESTo assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.Multicenter, open-label, phase 3 trial.DESIGNMulticenter, open-label, phase 3 trial.Sixty-nine sites in Europe and Russia.SETTINGSixty-nine sites in Europe and Russia.Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m2 .POPULATIONSexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m2 .E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.METHODSE4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.Pearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs.MAIN OUTCOME MEASURESPearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs.A total of 1553 women aged 18-50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15-1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women over Cycles 1 to 12 and lasted a median of 4-5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events.RESULTSA total of 1553 women aged 18-50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15-1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women over Cycles 1 to 12 and lasted a median of 4-5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events.E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.CONCLUSIONE4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.TWEETABLE ABSTRACTA phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16840 A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16840 To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Multicenter, open-label, phase 3 trial. Sixty-nine sites in Europe and Russia. Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m . E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary. Pearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs. A total of 1553 women aged 18-50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15-1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women over Cycles 1 to 12 and lasted a median of 4-5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events. E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile. A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. |
| Author | Apter, D Apolikhina, I Jost, M Foidart, J‐M Zatik, J Weyers, S Suturina, L Gemzell‐Danielsson, K Creinin, MD Piltonen, T |
| AuthorAffiliation | 3 Gynaecological Praxis St Anna Debrecen Hungary 4 Department of Obstetrics and Gynaecology University Hospital Gent Belgium 10 Department of Obstetrics and Gynaecology University of Liège Liège Belgium 2 VL‐Medi Clinical Research Centre Helsinki Finland 5 Department of Obstetrics and Gynaecology PEDEGO Research Unit Medical Research Center Oulu University Hospital University of Oulu Oulu Finland 6 Scientific Centre for Family Health and Human Reproduction Problems Irkutsk Russia 7 Kulakov National Medical Research Centre for Obstetrics, Gynaecology, and Perinatology Moscow Russia 9 Department of Obstetrics and Gynecology University of California Davis, Sacramento CA USA 8 Estetra SRL, an affiliate Company of Mithra Pharmaceuticals Liège Belgium 1 Department of Women's and Children's Health Karolinska Institutet Karolinska University Hospital Stockholm Sweden |
| AuthorAffiliation_xml | – name: 4 Department of Obstetrics and Gynaecology University Hospital Gent Belgium – name: 9 Department of Obstetrics and Gynecology University of California Davis, Sacramento CA USA – name: 2 VL‐Medi Clinical Research Centre Helsinki Finland – name: 8 Estetra SRL, an affiliate Company of Mithra Pharmaceuticals Liège Belgium – name: 6 Scientific Centre for Family Health and Human Reproduction Problems Irkutsk Russia – name: 7 Kulakov National Medical Research Centre for Obstetrics, Gynaecology, and Perinatology Moscow Russia – name: 3 Gynaecological Praxis St Anna Debrecen Hungary – name: 5 Department of Obstetrics and Gynaecology PEDEGO Research Unit Medical Research Center Oulu University Hospital University of Oulu Oulu Finland – name: 1 Department of Women's and Children's Health Karolinska Institutet Karolinska University Hospital Stockholm Sweden – name: 10 Department of Obstetrics and Gynaecology University of Liège Liège Belgium |
| Author_xml | – sequence: 1 givenname: K orcidid: 0000-0001-6516-1444 surname: Gemzell‐Danielsson fullname: Gemzell‐Danielsson, K organization: Karolinska University Hospital – sequence: 2 givenname: D surname: Apter fullname: Apter, D organization: VL‐Medi Clinical Research Centre – sequence: 3 givenname: J surname: Zatik fullname: Zatik, J organization: Gynaecological Praxis St Anna – sequence: 4 givenname: S surname: Weyers fullname: Weyers, S organization: University Hospital – sequence: 5 givenname: T surname: Piltonen fullname: Piltonen, T organization: University of Oulu – sequence: 6 givenname: L surname: Suturina fullname: Suturina, L organization: Scientific Centre for Family Health and Human Reproduction Problems – sequence: 7 givenname: I surname: Apolikhina fullname: Apolikhina, I organization: Kulakov National Medical Research Centre for Obstetrics, Gynaecology, and Perinatology – sequence: 8 givenname: M surname: Jost fullname: Jost, M email: mjost@mithra.com organization: Estetra SRL, an affiliate Company of Mithra Pharmaceuticals – sequence: 9 givenname: MD surname: Creinin fullname: Creinin, MD organization: University of California – sequence: 10 givenname: J‐M surname: Foidart fullname: Foidart, J‐M organization: University of Liège |
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| Copyright | 2021 Estetra SRL. : published by John Wiley & Sons Ltd. 2021 Estetra SRL. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. 2021. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | combined oral contraception estetrol contraceptive efficacy safety native estrogen drospirenone Bleeding pattern |
| Language | English |
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To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone... A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. This article includes Author... To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.... ObjectivesTo assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone... To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3... |
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| SubjectTerms | Acne Adolescent Adult Adverse events Birth control Bleeding Bleeding pattern Body mass index combined oral contraception Contraception contraceptive efficacy Contraceptives, Oral, Combined - administration & dosage Contraceptives, Oral, Combined - adverse effects drospirenone Effectiveness estetrol Estetrol - administration & dosage Estetrol - adverse effects Europe Female Hemorrhage Humans Menstruation Metrorrhagia Middle Aged native estrogen Oral contraceptives Patient safety Russia Safety Sexual intercourse Thromboembolism Vagina Womens health Young Adult |
| Title | Estetrol‐Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia |
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