Abstract | OBJECTIVE: METHODS: This study was a prospective, double-masked, randomized, multicenter trial. A total of 1176 healthy postmenopausal women age 45 years and older without evidence of endometrial abnormalities were randomly assigned to receive either unopposed E2 1 mg, or continuous-combined formulations of E2 1 mg and norethindrone acetate 0.1 mg, 0.25 mg, or 0.5 mg. Any spotting or bleeding episodes during the treatment period were recorded in a daily diary and reported by weekly telephone calls. RESULTS: The incidence of bleeding was low in the combination groups, even during the initial 3 months of treatment (24-28%), after which it decreased with increasing doses of norethindrone acetate. Conversely, the incidence of bleeding increased over time with unopposed E2 1 mg. After the initial 3 months, the incidence of bleeding among the combination groups was lowest in the norethindrone acetate 0.5 mg group. Among women initiating therapy close to menopause, fewer reported bleeding with norethindrone acetate 0.5 mg than with the other combination groups. There was a significantly (P<.05) lower discontinuation rate due to bleeding in the norethindrone acetate 0.5 mg group compared with all other treatment groups. CONCLUSION:
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Authors | D F Archer, M H Dorin, W Heine, N Nanavati, J C Arce |
Journal | Obstetrics and gynecology
(Obstet Gynecol)
Vol. 94
Issue 3
Pg. 323-9
(Sep 1999)
ISSN: 0029-7844 [Print] United States |
PMID | 10472853
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estradiol
- Norethindrone Acetate
- Norethindrone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Double-Blind Method
- Estradiol
(adverse effects)
- Estrogen Replacement Therapy
(adverse effects)
- Female
- Humans
- Incidence
- Middle Aged
- Norethindrone
(adverse effects, analogs & derivatives)
- Norethindrone Acetate
- Postmenopause
- Prospective Studies
- Uterine Hemorrhage
(chemically induced, epidemiology)
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