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Menopause is defined as the state of an absence of menstrual periods for 12 months. The menopausal transition starts with varying menstrual cycle length and ends with the final menstrual period. Perimenopause means "the time around menopause" and is often used to refer to the menopausal transitional period. It is not officially a medical term, but is sometimes used to explain certain aspects of the menopause transition in lay terms. Postmenopause is the entire period of time that comes after the last menstrual period.
Menopause is the time in a woman's life when the function of the ovaries ceases. The ovary (female gonad), is one of a pair of reproductive glands in women. They are located in the pelvis, one on each side of the uterus. Each ovary is about the size and shape of an almond. The ovaries produce eggs (ova) and female hormones such as estrogen. During each monthly menstrual cycle, an egg is released f...
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Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
EstroGel (estradiol gel) 1.25 g was studied in 2 well-controlled 12-week clinical trials. Incidence of adverse events ≥ 5 percent for 1.25 g EstroGel (estradiol gel) and placebo is given below in Table 4.
TABLE 4: Incidence of Treatment-emergent Signs and Symptoms
≥ 5 Percent By COSTART Body System and by Descending Frequency of Occurrence
in the EstroGel (estradiol gel) Treatment Group for the Intent-to-Treat Safety Population in
2 Well-controlled Clinical Studies (Expressed as Percent of Treatment Group)
| Body System/Treatment-emergent Signs and Symptoms |
EstroGel 1.25 g day (n=168) |
Placebo (n=73) |
| BODY AS A WHOLE | ||
| Headache | 20.2 | 17.8 |
| Infection* | 17.3 | 6.8 |
| Pain† | 7.1 | 11.0 |
| Abdominal pain | 7.7 | 1.4 |
| Back pain | 4.8 | 4.1 |
| Flu syndrome | 5.4 | 1.4 |
| Asthenia | 4.8 | 4.1 |
| CARDIOVASCULAR SYSTEM | ||
| Palpitations | 0.6 | 1.4 |
| DIGESTIVE SYSTEM | ||
| Nausea | 6.0 | 4.1 |
| Flatulence | 6.5 | 5.5 |
| Diarrhea | 4.2 | 0.0 |
| METABOLIC and NUTRITIONAL SYSTEMS | ||
| Weight gain | 2.4 | 0.0 |
| NERVOUS SYSTEM | ||
| Nervousness | 2.4 | 1.4 |
| Depression | 3.0 | 2.7 |
| Anxiety | 1.8 | 0.0 |
| RESPIRATORY SYSTEM | ||
| Sinusitis | 3.6 | 1.4 |
| Rhinitis | 2.4 | 6.8 |
| SKIN AND APPENDAGES | ||
| Rash‡ | 7.1 | 5.5 |
| Pruritus‡ | 4.8 | 2.7 |
| Application-site reaction | 0.6 | 0.0 |
| UROGENITAL | ||
| Breast pain | 12.5 | 9.6 |
| Metrorrhagia | 3.0 | 0.0 |
| Endometrial disorder§ | 1.8 | 1.4 |
| Vaginitis | 8.9 | 4.1 |
| Pap smear suspicious|| | 5.4 | 2.7 |
| Vaginal hemorrhage | 1.2 | 0.0 |
| *Infection: upper respiratory infection, common cold, eye
infection. †Pain: generalized and extremity aches/pains, cramps. ‡Rash and pruritus: more than half of the EstroGel (estradiol gel) -treated patients who had pruritus reported itching at a body site other than the arms or reported generalized itching or itching skin. Similarly, most of the EstroGel (estradiol gel) -treated patients with rash had rash on 1 or more areas of the body in addition to the arms. §Endometrial disorder: proliferative endometrium, benign endometrial disorders. || Pap smear suspicious: atypical squamous cells of undetermined significance, inflammatory changes, epithelial cell abnormality. |
||
The following additional adverse events have been reported with estrogen and/or progestin therapy.
Last reviewed on RxList: 2/12/2008
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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