ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia.)
The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)
The estrogen-plus-progestin substudy of the WHI reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer . )
The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES, WARNINGS, Dementia, and PRECAUTIONS, Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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DIVIGEL SUMMARY
Divigel® (estradiol gel) 0.1% is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin, quick-drying layer.
Divigel® (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause.
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NEWS HIGHLIGHTS
Published Studies Related to Divigel (Estradiol Topical)
Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. [2009.01]
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of three doses of estradiol gel 0.1% (Divigel, a novel formulation consisting of 1 mg estradiol per 1 g transdermal gel) to reduce the frequency and severity of vasomotor symptoms and signs of vulvar and vaginal atrophy associated with menopause... CONCLUSIONS: Low-dose transdermal estradiol gel 0.1% is an effective treatment for relief of vasomotor symptoms, as well as signs of vulvar and vaginal atrophy, associated with menopause. Estradiol gel 0.1% offers multiple dosing options to individualize patient therapy, including the lowest available effective dose (0.25 mg estradiol, delivering 0.003 mg/d estradiol) to treat the vasomotor symptoms of menopause.
Estradiol in micellar nanoparticles: the efficacy and safety of a novel transdermal drug-delivery technology in the management of moderate to severe vasomotor symptoms. [2006.03]
OBJECTIVE: To assess the efficacy and safety of topical micellar nanoparticle estradiol emulsion (MNPEE; Estrasorb; Novavax, Inc., Malvern, PA) in postmenopausal women with moderate to severe vasomotor symptoms... CONCLUSION: Once-daily application of 3.45 g of micellar nanoparticle estradiol emulsion containing 8.6 mg of estradiol was safe and effective in providing significant relief of vasomotor symptom frequency and severity in postmenopausal women.
Prediction of incident osteoporotic fractures in elderly women using the free estradiol index. [2005.02]
A decline in postmenopausal estrogen concentration accelerates postmenopausal bone loss. We have examined the predictive power of endogenous estrogen production, DXA hip bone density (BMD), and heel quantitative ultrasound (QUS) on incident clinical fracture in a prospective 3-year population based, randomised controlled trial of calcium supplementation...
Serum concentrations of 17beta-estradiol and estrone after multiple-dose administration of percutaneous estradiol gel in symptomatic menopausal women. [2001.04]
In two multicenter phase III efficacy studies, blood samples were obtained to evaluate the serum concentrations of 17beta-estradiol (E2) and unconjugated estrone (E1) after administration of a percutaneous gel or transdermal patch containing estradiol... However, the 0.625-g gel dose did not produce E2 levels in a range expected to be consistently therapeutic in most postmenopausal women.
Effect of an estradiol gel with monthly or quarterly progestogen on menopausal symptoms and bleeding. [2000.12]
OBJECTIVE: To assess the acceptability, efficacy and endometrial safety of transdermal estradiol gel (Divigel/Sandrena) combined with monthly or quarterly oral progestogen (medroxyprogesterone acetate)... CONCLUSIONS: Both the 1- and 3-month regimens were equally effective in controlling climacteric symptoms and protecting against endometrial hyperstimulation. The bleeding patterns were comparable between groups and were similar to those reported for oral estrogens. Estradiol gel was highly acceptable to the majority of women.
Clinical Trials Related to Divigel (Estradiol Topical)
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen [Recruiting]
The purpose of this study is to see if Vagifem® is safe for women who have had breast
cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the
vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not
to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a
new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the
vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise
in your estrogen level. However, there is no clear evidence that this would cause any bad
effects in patients with breast cancer. How much, if any, of these topical estrogens are
absorbed through the vagina is not known. We also do not know what the impact is of low
dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as
the mucus membranes are restored after estrogen exposure.
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients [Recruiting]
The purpose of this clinical research study is to determine whether the ESTRING or a special
preparation of a testosterone cream inserted vaginally are safe for use in breast cancer
patients. This study will also evaluate if either of these treatments can improve symptoms
of vaginal dryness or decreased sexual interest that are related to your treatment for
breast cancer.
Initiating Transdermal Estradiol Therapy in Turner's Syndrome [Recruiting]
This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses
of estradiol administered by recently available transdermal patches for the initiation of
puberty in Turner syndrome girls 11. 5-13. 0 years old in conjunction with growth hormone (GH)
therapy.
The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment,
low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating
feminization, height velocity, and bone mineral density without compromising growth
potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior
to GH alone in effects on feminization, height velocity, and bone mineral density.
Postpartum Depression: Transdermal Estradiol Versus Sertraline [Recruiting]
The purpose of this study is to determine whether estrogen patches are effective for the
treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.
A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC [Not yet recruiting]
We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the
number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel
intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo.
The objective of this study is to compare the total number of days of bleeding experienced
by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared
to those randomized to placebo for the first 12 weeks of use. We will enroll women
initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo.
We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for
16 weeks which will be used to calculate the total number of bleeding or spotting days.
Statistical analysis will be performed to evaluate if there is less bleeding among the
treatment arms then the placebo arm.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Divigel has an overall score of 9.50. The effectiveness score is 9 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Divigel review by 48 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | vaginal dryness, night sweats |
| Dosage & duration: | | 0.1% 0.5 mg taken once daily for the period of 3 months so far |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | The Night sweats are almost non-existent now - occurring very irregularly and the vaginal dryness is remarkably better. |
| Side effects: | | I have found no side effects so far. |
| Comments: | | Application of one gel packet once daily to either thigh. I have found that during one week of the month when the vaginal dryness is at it's peak it helps to use two packets. This was approved by my physician. |
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| | Divigel review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | HRT |
| Dosage & duration: | | 0.1% (dosage frequency: everyday) for the period of 1 month |
| Other conditions: | | Depression |
| Other drugs taken: | | Lexapro and Seroquel | | |
Reported Results |
| Benefits: | | This worked better than an estrogen patch. I felt better and vagainal atrophy was almost cleared up. |
| Side effects: | | None that I can tell. |
| Comments: | | Rub one packet of gel on the top of either thigh daily. |
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Page last updated: 2009-10-20
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