[A "no-bleeding" substitute hormone treatment with an oral microdose progesterone. A prospective multicenter study].
OBJECTIVE
Study of influence of different sequences of oral micronized progesterone (Pg) on endometrial morphology and the incidence of bleeding.


METHODS
Prospective comparative multicentric study conducted in 101 post-menopausal patients.


METHODS
98 patients who did not wish any regular withdrawal bleeding were given percutaneous oestradiol 17-beta (E2) (1.5 mg/d) associated with micronized Pg (100 mg/d) at bedtime during either 21 out of 28 days (group I), or 25 days per calendar month (group III), during a minimum of 6 months. For those wishing withdrawal bleeding (n = 3), E2 (3 mg/d) during 25 days was associated with Pg (300 mg/d) from the 16th to the 25th day of the month (group III). Endometrial biopsies were performed after 6 months of the same treatment and blindly analysed; transvaginal ultrasonography (measurement of endometrial mucosa thickness) was done in case of insufficient amount of tissue.


RESULTS
Groups I and II: 61% of the endometrium were quiescent without mitosis, 23% were slightly active with rare mitoses, 8% partly secretory and 4% subatrophic. Sampling was inadequate in the remaining 4%. Mitotic activity of glands was low on the overall samplings (average < 0.53/1,000 cells). The average mucosa thickness was at 3.9 mm. No bleeding (spotting or withdrawal bleeding) occurred in 73.3% and 82.1% of cycles at the 3rd and 6th months of administration, respectively. Group III: endometrium were quiescent or slightly active and combined with frequent withdrawal bleeding.


CONCLUSIONS
A relatively low dose of oral progesterone (100 mg/d) combined with E2 during 21d/28d or 25 d/month efficiently controls proliferation, induces a very low endometrial cyclic activity--while reducing spottings--and maintains an amenorrhea in the majority of women. This simple treatment is likely to improve compliance.
Gillet
J Y
JY
Service de Gynécologie-Obstétrique, Hôpital Saint-Roch, Nice.
Faguer
B
B
André
G
G
Magnin
G
G
de Lignières
B
B
Philippe
E
E
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000568:Amenorrhea / Q000503:physiopathology; D002455:Cell Division; D004717:Endometrium / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D008938:Mitosis; D017060:Patient Satisfaction; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D011374:Progesterone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D014463:Ultrasonography
D011374:Progesterone; D004958:Estradiol
Recherche d'un traitement hormonal substitutif "sans règles" avec la progestérone micronisée orale. Etude multicentrique prospective.