Hormone withdrawal-associated symptoms: Comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate

Jeffrey Jensen, Susanne Parke, Uwe Mellinger, Marco Serrani, R. Garn Mabey

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Objectives To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs). Methods This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28. Results In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM). Conclusions E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.

Original languageEnglish (US)
Pages (from-to)274-283
Number of pages10
JournalEuropean Journal of Contraception and Reproductive Health Care
Volume18
Issue number4
DOIs
StatePublished - Aug 2013

Fingerprint

Substance Withdrawal Syndrome
Ethinyl Estradiol
Hormones
Pelvic Pain
Contraceptives, Oral, Combined
Headache
Visual Analog Scale
norgestimate
estradiol valerate-dienogest
Therapeutics

Keywords

  • Dienogest
  • Headache
  • Hormone withdrawal-associated symptoms
  • Oestradiol valerate
  • Oral contraception

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Pharmacology (medical)
  • Reproductive Medicine

Cite this

Hormone withdrawal-associated symptoms : Comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. / Jensen, Jeffrey; Parke, Susanne; Mellinger, Uwe; Serrani, Marco; Mabey, R. Garn.

In: European Journal of Contraception and Reproductive Health Care, Vol. 18, No. 4, 08.2013, p. 274-283.

Research output: Contribution to journalArticle

@article{8d1f7caacb884c5ab14b57700e44ddd3,
title = "Hormone withdrawal-associated symptoms: Comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate",
abstract = "Objectives To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs). Methods This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28. Results In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35{\%} E2V/DNG vs. 34{\%} EE/NGM). Conclusions E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.",
keywords = "Dienogest, Headache, Hormone withdrawal-associated symptoms, Oestradiol valerate, Oral contraception",
author = "Jeffrey Jensen and Susanne Parke and Uwe Mellinger and Marco Serrani and Mabey, {R. Garn}",
year = "2013",
month = "8",
doi = "10.3109/13625187.2013.785516",
language = "English (US)",
volume = "18",
pages = "274--283",
journal = "European Journal of Contraception and Reproductive Health Care",
issn = "1362-5187",
publisher = "Informa Healthcare",
number = "4",

}

TY - JOUR

T1 - Hormone withdrawal-associated symptoms

T2 - Comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate

AU - Jensen, Jeffrey

AU - Parke, Susanne

AU - Mellinger, Uwe

AU - Serrani, Marco

AU - Mabey, R. Garn

PY - 2013/8

Y1 - 2013/8

N2 - Objectives To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs). Methods This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28. Results In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM). Conclusions E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.

AB - Objectives To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs). Methods This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28. Results In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM). Conclusions E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.

KW - Dienogest

KW - Headache

KW - Hormone withdrawal-associated symptoms

KW - Oestradiol valerate

KW - Oral contraception

UR - http://www.scopus.com/inward/record.url?scp=84880290153&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84880290153&partnerID=8YFLogxK

U2 - 10.3109/13625187.2013.785516

DO - 10.3109/13625187.2013.785516

M3 - Article

C2 - 23638631

AN - SCOPUS:84880290153

VL - 18

SP - 274

EP - 283

JO - European Journal of Contraception and Reproductive Health Care

JF - European Journal of Contraception and Reproductive Health Care

SN - 1362-5187

IS - 4

ER -