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Fertil Steril. 1991 Dec;56(6):1040-7.

Factors associated with withdrawal bleeding after administration of oral micronized progesterone in women with secondary amenorrhea.

Author information

1
Department of Obstetrics and Gynecology, Hahnemann University, Philadelphia, Pennsylvania 19102.

Abstract

OBJECTIVE:

To compare two dosages of oral micronized progesterone (P) and placebo for withdrawal bleeding and side effects.

DESIGN:

Prospective, randomized, double-blind.

SETTING:

Academic institution.

PARTICIPANTS:

Out of 190 screened with oligomenorrhea/amenorrhea, 60 who qualified completed the study.

INTERVENTIONS:

A 10-day course of (1) oral micronized P 300 mg, (2) oral micronized P 200 mg, or (3) placebo.

MAIN OUTCOME MEASURES:

Withdrawal bleeding, side effects, and changes in lipids. Endogenous estradiol (E2) concentrations at baseline and P concentrations during treatment were correlated with bleeding response.

RESULTS:

Withdrawal bleeding occurred in 90% of women taking 300 mg, 58% of women taking 200 mg, and 29% of women taking placebo (P less than 0.0002 for 300 mg versus placebo). Side effects occurred similarly among the groups (P = not significant). Lipid concentrations were unchanged. Endogenous E2 and treatment P concentrations were of limited predictive value for withdrawal bleeding.

CONCLUSIONS:

Progesterone 300 mg induced significantly more withdrawal bleeding than placebo, with similar side effects. Bleeding response cannot be predicted reliably from E2 and P concentrations.

PMID:
1743319
[Indexed for MEDLINE]

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