Bleeding patterns during continuous estradiol with different sequential progestogens therapy

Costantino Di Carlo, Annalidia Sammartino, Attilio Di Spiezio Sardo, Giovanni A. Tommaselli, Maurizio Guida, Vincenzo D. Mandato, Antonio D'Elia, Carmine Nappi

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: To evaluate the effects on monthly bleeding of four different progestogens administered in association with transdermal estradiol in a continuous sequential estrogen-progestin therapy (CS-EPT). Design: This prospective, open, randomized, clinical trial included 100 healthy postmenopausal women. Patients were randomized into four treatment groups, each consisting of 25 women. Treatment consisted of 50 μg/day transdermal 17β-estradiol for all women combined to receive four different progestogens (group A: medroxyprogesterone acetate, 10 mg/day; group B: nomegestrol acetate, 5 mg/day; group C: dydrogesterone, 10 mg/day; group D: micronized progesterone, 200 mg/day) per os from the 14th to 25th day of each 28-day cycle. The duration of treatment was 12 cycles. Patients were asked to record in a daily diary the occurrence of any vaginal bleeding, the days of application of each patch, the days of assumption of the different progestogens, and the exact moment of bleeding onset. Results: A total of 937 cycles could be evaluated. In 690 cycles (73.6%), regular progestogen-related bleeding was reported. Among the other cycles, we observed 73 episodes of amenorrhea (7.8%, each one lasting one cycle), 78 episodes of irregular bleeding (8.3%), and 96 episodes of spotting (10.2%). Patients receiving nomegestrol acetate had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving medroxyprogesterone acetate or natural progesterone, and patients receiving dydrogesterone had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving natural progesterone. Conclusion: Our data suggest that CS-EPT generally leads to regular withdrawal bleeding in women without uterine pathology. Micronized progesterone seems to induce more irregular bleeding episodes.

Original languageEnglish
Pages (from-to)520-525
Number of pages6
JournalMenopause
Volume12
Issue number5
DOIs
Publication statusPublished - 2005

Fingerprint

Progestins
Estradiol
Hemorrhage
nomegestrol acetate
Progesterone
Dydrogesterone
Medroxyprogesterone Acetate
Therapeutics
Estrogens
Metrorrhagia
Uterine Hemorrhage
Amenorrhea
Incidence
Randomized Controlled Trials
Pathology

Keywords

  • Endometrium
  • Hormone therapy
  • Progestogens
  • Transdermal estradiol
  • Vaginal bleeding

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Di Carlo, C., Sammartino, A., Di Spiezio Sardo, A., Tommaselli, G. A., Guida, M., Mandato, V. D., ... Nappi, C. (2005). Bleeding patterns during continuous estradiol with different sequential progestogens therapy. Menopause, 12(5), 520-525. https://doi.org/10.1097/01.gme.0000178450.29377.c9

Bleeding patterns during continuous estradiol with different sequential progestogens therapy. / Di Carlo, Costantino; Sammartino, Annalidia; Di Spiezio Sardo, Attilio; Tommaselli, Giovanni A.; Guida, Maurizio; Mandato, Vincenzo D.; D'Elia, Antonio; Nappi, Carmine.

In: Menopause, Vol. 12, No. 5, 2005, p. 520-525.

Research output: Contribution to journalArticle

Di Carlo, C, Sammartino, A, Di Spiezio Sardo, A, Tommaselli, GA, Guida, M, Mandato, VD, D'Elia, A & Nappi, C 2005, 'Bleeding patterns during continuous estradiol with different sequential progestogens therapy', Menopause, vol. 12, no. 5, pp. 520-525. https://doi.org/10.1097/01.gme.0000178450.29377.c9
Di Carlo, Costantino ; Sammartino, Annalidia ; Di Spiezio Sardo, Attilio ; Tommaselli, Giovanni A. ; Guida, Maurizio ; Mandato, Vincenzo D. ; D'Elia, Antonio ; Nappi, Carmine. / Bleeding patterns during continuous estradiol with different sequential progestogens therapy. In: Menopause. 2005 ; Vol. 12, No. 5. pp. 520-525.
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abstract = "Objective: To evaluate the effects on monthly bleeding of four different progestogens administered in association with transdermal estradiol in a continuous sequential estrogen-progestin therapy (CS-EPT). Design: This prospective, open, randomized, clinical trial included 100 healthy postmenopausal women. Patients were randomized into four treatment groups, each consisting of 25 women. Treatment consisted of 50 μg/day transdermal 17β-estradiol for all women combined to receive four different progestogens (group A: medroxyprogesterone acetate, 10 mg/day; group B: nomegestrol acetate, 5 mg/day; group C: dydrogesterone, 10 mg/day; group D: micronized progesterone, 200 mg/day) per os from the 14th to 25th day of each 28-day cycle. The duration of treatment was 12 cycles. Patients were asked to record in a daily diary the occurrence of any vaginal bleeding, the days of application of each patch, the days of assumption of the different progestogens, and the exact moment of bleeding onset. Results: A total of 937 cycles could be evaluated. In 690 cycles (73.6{\%}), regular progestogen-related bleeding was reported. Among the other cycles, we observed 73 episodes of amenorrhea (7.8{\%}, each one lasting one cycle), 78 episodes of irregular bleeding (8.3{\%}), and 96 episodes of spotting (10.2{\%}). Patients receiving nomegestrol acetate had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving medroxyprogesterone acetate or natural progesterone, and patients receiving dydrogesterone had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving natural progesterone. Conclusion: Our data suggest that CS-EPT generally leads to regular withdrawal bleeding in women without uterine pathology. Micronized progesterone seems to induce more irregular bleeding episodes.",
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AB - Objective: To evaluate the effects on monthly bleeding of four different progestogens administered in association with transdermal estradiol in a continuous sequential estrogen-progestin therapy (CS-EPT). Design: This prospective, open, randomized, clinical trial included 100 healthy postmenopausal women. Patients were randomized into four treatment groups, each consisting of 25 women. Treatment consisted of 50 μg/day transdermal 17β-estradiol for all women combined to receive four different progestogens (group A: medroxyprogesterone acetate, 10 mg/day; group B: nomegestrol acetate, 5 mg/day; group C: dydrogesterone, 10 mg/day; group D: micronized progesterone, 200 mg/day) per os from the 14th to 25th day of each 28-day cycle. The duration of treatment was 12 cycles. Patients were asked to record in a daily diary the occurrence of any vaginal bleeding, the days of application of each patch, the days of assumption of the different progestogens, and the exact moment of bleeding onset. Results: A total of 937 cycles could be evaluated. In 690 cycles (73.6%), regular progestogen-related bleeding was reported. Among the other cycles, we observed 73 episodes of amenorrhea (7.8%, each one lasting one cycle), 78 episodes of irregular bleeding (8.3%), and 96 episodes of spotting (10.2%). Patients receiving nomegestrol acetate had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving medroxyprogesterone acetate or natural progesterone, and patients receiving dydrogesterone had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving natural progesterone. Conclusion: Our data suggest that CS-EPT generally leads to regular withdrawal bleeding in women without uterine pathology. Micronized progesterone seems to induce more irregular bleeding episodes.

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