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Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature.

Nappi RE, Serrani M, Jensen JT - Int J Womens Health (2014)

Bottom Line: To date, E2V/DNG is the only oral contraceptive approved for this indication.Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel.Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Research Centre for Reproductive Medicine, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy.

ABSTRACT
Combined oral contraceptives formulated to include estradiol (E2) have recently become available for the indication of pregnancy prevention. A combined estradiol valerate and dienogest pill (E2V/DNG), designed to be administered using an estrogen step-down and a progestin step-up regimen over 26 days of active treatment followed by 2 days of placebo (26/2-day regimen), has also undergone research to assess the potential for additional noncontraceptive benefits. Randomized, placebo-controlled studies have demonstrated that E2V/DNG is an effective treatment for heavy menstrual bleeding - a reduction in median menstrual blood loss approaching 90% occurs after 6 months of treatment. To date, E2V/DNG is the only oral contraceptive approved for this indication. Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel. Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review.

No MeSH data available.


Related in: MedlinePlus

Scores of the Female Sexual Function Index subdomains, for E2V/DNG and EE/LNG, at baseline and cycle 6, and the change from baseline.Note: Reproduced from Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. Davis SR, Bitzer J, Giraldi A, et al. J Sex Med. 2013;10(12):3069–3079. Copyright © 2013 International Society for Sexual Medicine.34Abbreviations: DNG, dienogest; E2V, estradiol valerate; EE, ethinyl estradiol; FSFI, Female Sexual Function Index, LNG, levonorgestrel.
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f3-ijwh-6-711: Scores of the Female Sexual Function Index subdomains, for E2V/DNG and EE/LNG, at baseline and cycle 6, and the change from baseline.Note: Reproduced from Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. Davis SR, Bitzer J, Giraldi A, et al. J Sex Med. 2013;10(12):3069–3079. Copyright © 2013 International Society for Sexual Medicine.34Abbreviations: DNG, dienogest; E2V, estradiol valerate; EE, ethinyl estradiol; FSFI, Female Sexual Function Index, LNG, levonorgestrel.

Mentions: Oral contraceptives are not thought to improve sexual function, aside from the reduction in concern for risk of pregnancy. However, oral contraceptives containing progestins with antiandrogenic activity, such as DNG, may theoretically be associated with decreased libido,57 and it is common for women with associated sexual dysfunction to be switched to oral contraceptives containing progestins with androgenic activity, such as LNG.34 A preliminary study in 57 sexually active, healthy women showed that E2V/DNG improved QoL and had a positive effect on sexuality over six cycles of use;24 however, this study was open label, and without a comparator. More recently, a multicenter, double-blind, noninferiority RCT compared the effects of six cycles of E2V/DNG with EE/LNG on sexual function, in 276 women with COC-associated sexual dysfunction.34 Similar improvements in all domains of the Female Sexual Function Index (FSFI) were demonstrated with E2V/DNG and EE/LNG recipients, with no significant between-group differences (Figure 3). The mean increase (improvement) in the sum of the FSFI Desire and Arousal component scores from baseline to cycle 6 were 5.90±5.45 for E2V/DNG and 5.79±6.17 for EE/LNG (both P<0.0001), and all other efficacy parameters were also equally improved with the two COCs. Overall, these results suggest that E2V/DNG does not have a detrimental effect on sexual function.


Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature.

Nappi RE, Serrani M, Jensen JT - Int J Womens Health (2014)

Scores of the Female Sexual Function Index subdomains, for E2V/DNG and EE/LNG, at baseline and cycle 6, and the change from baseline.Note: Reproduced from Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. Davis SR, Bitzer J, Giraldi A, et al. J Sex Med. 2013;10(12):3069–3079. Copyright © 2013 International Society for Sexual Medicine.34Abbreviations: DNG, dienogest; E2V, estradiol valerate; EE, ethinyl estradiol; FSFI, Female Sexual Function Index, LNG, levonorgestrel.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4128844&req=5

f3-ijwh-6-711: Scores of the Female Sexual Function Index subdomains, for E2V/DNG and EE/LNG, at baseline and cycle 6, and the change from baseline.Note: Reproduced from Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. Davis SR, Bitzer J, Giraldi A, et al. J Sex Med. 2013;10(12):3069–3079. Copyright © 2013 International Society for Sexual Medicine.34Abbreviations: DNG, dienogest; E2V, estradiol valerate; EE, ethinyl estradiol; FSFI, Female Sexual Function Index, LNG, levonorgestrel.
Mentions: Oral contraceptives are not thought to improve sexual function, aside from the reduction in concern for risk of pregnancy. However, oral contraceptives containing progestins with antiandrogenic activity, such as DNG, may theoretically be associated with decreased libido,57 and it is common for women with associated sexual dysfunction to be switched to oral contraceptives containing progestins with androgenic activity, such as LNG.34 A preliminary study in 57 sexually active, healthy women showed that E2V/DNG improved QoL and had a positive effect on sexuality over six cycles of use;24 however, this study was open label, and without a comparator. More recently, a multicenter, double-blind, noninferiority RCT compared the effects of six cycles of E2V/DNG with EE/LNG on sexual function, in 276 women with COC-associated sexual dysfunction.34 Similar improvements in all domains of the Female Sexual Function Index (FSFI) were demonstrated with E2V/DNG and EE/LNG recipients, with no significant between-group differences (Figure 3). The mean increase (improvement) in the sum of the FSFI Desire and Arousal component scores from baseline to cycle 6 were 5.90±5.45 for E2V/DNG and 5.79±6.17 for EE/LNG (both P<0.0001), and all other efficacy parameters were also equally improved with the two COCs. Overall, these results suggest that E2V/DNG does not have a detrimental effect on sexual function.

Bottom Line: To date, E2V/DNG is the only oral contraceptive approved for this indication.Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel.Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Research Centre for Reproductive Medicine, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy.

ABSTRACT
Combined oral contraceptives formulated to include estradiol (E2) have recently become available for the indication of pregnancy prevention. A combined estradiol valerate and dienogest pill (E2V/DNG), designed to be administered using an estrogen step-down and a progestin step-up regimen over 26 days of active treatment followed by 2 days of placebo (26/2-day regimen), has also undergone research to assess the potential for additional noncontraceptive benefits. Randomized, placebo-controlled studies have demonstrated that E2V/DNG is an effective treatment for heavy menstrual bleeding - a reduction in median menstrual blood loss approaching 90% occurs after 6 months of treatment. To date, E2V/DNG is the only oral contraceptive approved for this indication. Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel. Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review.

No MeSH data available.


Related in: MedlinePlus