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J Studd

Publications and source records attributed to J Studd.

At least 37 records · Page 2Linked to original sources
PubMed1996

Comparison of two estradiol transdermal systems (Oesclim 50 and Estraderm TTS 50). I. Tolerability, adhesion and efficacy.

OBJECTIVES: The objectives were to compare the tolerability, adhesion and efficacy of a new matrix-type estradiol transdermal system, Oesclim 50, with those of Estraderm TTS 50, a reservoir-type system. METHODS: This was an open, randomised, parallel-group, multi-centre clinical trial, performed in six European countries. A total of 143 healthy menopausal women were allocated to treatment with Oesclim 50 and 140 to Estraderm TTS 50. The transdermal systems were applied twice weekly for 24 days out of each 28-day cycle, over a period of four cycles. Oral progestogen treatment was taken by non-hysterectomised patients for the last 12 days of estrogen therapy in each cycle. RESULTS: The local skin tolerability of the Oesclim 50 transdermal system was significantly better than that of Estraderm TTS 50. In the Oesclim 50 group, 4.2% of applications caused a reaction, compared with 9.5% in the Estraderm TTS 50 group (P < 0.001). Safety assessments showed both treatments to be well tolerated. Seven patients in the Oesclim 50 group, and 12 in the Estraderm TTS 50 group, discontinued due to adverse events. Of these discontinuations, one (0.7% of patients) in the Oesclim 50 group and seven (5.1% of patients) in the Estraderm TTS 50 group were due to application site reactions (P < 0.05). There was no statistically significant difference between the two groups in the percentage of patients with signs of hyperestrogenism (29 patients (20.3%) in the Oesclim group and 28 patients (20.0%) in the Estraderm TTS 50 group). Adhesion was significantly better for the Oesclim 50 transdermal system, with 6.0% of Oesclim 50 applications becoming detached compared with 11.3% of Estraderm TTS 50 applications (P < 0.001). The greater adhesion of Oesclim 50 was particularly apparent when the systems were exposed to water, with three times fewer Oesclim 50 systems becoming detached during a shower or bath (P < 0.001 in each case). Both treatments produced significant and comparable improvements in vasomotor symptoms, other menopausal symptoms and gynaecological assessments. A near-maximal effect on vasomotor symptoms was observed after approximately 1 month of treatment, and was maintained for the entire treatment period. CONCLUSION: Overall, Oesclim 50 provided statistically significantly better local skin tolerability and adhesion than Estraderm TTS 50, together with comparable efficacy and safety.

Administration, Cutaneous↗
PubMed1996

Comparison of two estradiol transdermal systems (Oesclim 50 and Estraderm TTS 50). II. Local skin tolerability.

OBJECTIVES: The objectives were to compare the local skin tolerability of a matrix-type estradiol transdermal system, Oesclim 50, with that of the reservoir-type system, Estraderm TTS 50. METHODS: Two randomised studies were performed. In the first study, the modified Draize-Shelanski-Jordan method of sensitization was used in an open, parallel-group trial to compare the cutaneous tolerability of repeated applications of Oesclim 50 with that of Estraderm TTS 50 in 24 healthy postmenopausal women. The second study was an open, randomised, parallel-group, multi-centre clinical trial involving 283 healthy menopausal women. A total of 143 women were allocated to treatment with Oesclim 50 and 140 to Estraderm TTS 50. The treatment duration was four months. RESULTS: The first study showed that the treatments, Oesclim 50 and Estraderm TTS 50, had no sensitizing potential and did not induce allergic reactions. In the second study, 4.2% of applications in the Oesclim group provoked reactions compared with 9.5% in the Estraderm group (P < 0.001). Thirty-seven patients (25.9%) treated with Oesclim and 55 patients (39.9%) receiving Estraderm experienced one or more reactions (P < 0.05). Redness and itching were the most frequent types of application site reaction in both treatment groups. The durations of the reactions were significantly shorter in the Oesclim group (P < 0.01), with a higher percentage of durations of less than 1 h and a lower percentage of durations of over 48 h than in the Estraderm TTS 50 group. None of the reactions in the Oesclim group led to premature removal of the patch, compared with 11 (3.4%) in the Estraderm group (P < 0.05). The number of patients who discontinued treatment due to application site reactions was one (0.7%) in the Oesclim group and seven (5.1%) in the Estraderm group (P < 0.05). Efficacy and general safety were comparable in the two treatment groups. CONCLUSIONS: In the first study, neither Oesclim nor Estraderm induced allergic reactions. In the second study, the local skin tolerability of Oesclim was significantly better than that of Estraderm, in terms of the number, duration and severity of the application site reactions.

Administration, Cutaneous↗
PubMed1996

HRT and long-term compliance: the efficacy and safety of Menorest.

Hormone replacement therapy (HRT) is perhaps the most important development in preventive medicine in the Western world for half a century, yet long-term compliance is notoriously poor. Up to 75% of women who start on HRT are reported to drop out within the first 6 months. Poor compliance may arise from a lack of awareness of the benefits of HRT, or from a number of common misconceptions, particularly the idea that HRT is ¿unnatural', and will cause weight gain, cancer, or unpleasant side effects. While side effects (usually progestogenic) may of course occur on HRT, they can usually be managed by a change in the regimen. Studies of the efficacy and safety of Menorest, an adhesive matrix transdermal system, used in combination with dydrogesterone for 12 days in each cycle, show it to be effective in relieving menopausal symptoms and increasing lumbar and spinal bone mass. Menorest was as effective and well-tolerated as a reference oral treatment (conjugated estrogens), and its twice weekly application may be considered to promote compliance.

Administration, Cutaneous↗
PubMed1996

Hormone replacement therapy for women after breast carcinoma.

The use of hormone replacement therapy after the diagnosis of breast cancer has been contra-indicated because of the fear of precipitating a relapse. However, many survivors of breast cancer experience debilitating symptoms as a consequence of oestrogen deficiency and over the long term are at an increased risk of dying prematurely from cardiovascular disease or a hip fractures because they are denied hormone replacement therapy. The past year saw definitive reviews on this subject as well as publication of the largest case-controlled study of hormone therapy in women with a history of breast cancer. The encouraging findings of these non-randomized studies have prompted the commencement of prospective studies to evaluate the benefits and risks of this practice. It is no longer contra-indicated to prescribe hormone replacement therapy to selected women after a history of breast cancer but it remains controversial and more information is required.

Breast Neoplasms↗
PubMed1996

The need for add-back with gonadotrophin-releasing hormone agonist therapy.

The usefulness of the gonadotrophin-releasing hormone (GnRH) agonists in treating benign chronic gynaecological disorders, such as endometriosis and uterine fibroids, or pre-menstrual syndrome (PMS), is limited by their hypo-oestrogenic side effects, including bone demineralisation and vasomotor symptoms. Studies in patients receiving GnRH agonists and hormone replacement therapy (HRT) show that whilst the efficacy of GnRH agonist monotherapy in treating endometriosis and fibroids is maintained, the concomitant add-back HRT can prevent the bone loss and reduce the incidence and severity of vasomotor symptoms. However, in a study of add-back HRT (an oestrogenic plus a progestogenic agent) in severe PMS, although the efficacy of Zoladex (goserelin acetate) against oestrogen-responsive symptoms, such as mood, was still evident, progestogenic side effects still occurred. It is likely that add-back HRT may need to be tailored to individual indications.

Adult↗
PubMed1995

Exogenous androgens in postmenopausal women.

There is an increasing awareness that androgens are of therapeutic value in postmenopausal women. Evidence is emerging demonstrating the role of testosterone in both female embryologic development and normal sexual behavior and mood. Women who are androgen depleted develop physical and behavioral symptoms referred to as female androgen deficiency syndrome. To a lesser degree, women who undergo an oophorectomy are deprived of endogenous ovarian androgens and have consistently been shown to have impairment of sexual functioning, loss of energy, depression, and headaches. Testosterone seems to act synergistically with estrogen in the treatment of these symptoms. The combination of estradiol and testosterone has been shown to have a beneficial effect on the skeleton, although not significantly better than estradiol therapy alone. Cosmetic side effects are rare if supraphysiologic doses are avoided. The potential metabolic complications have not been consistently demonstrated in studies to date. Androgen replacement therapy is a neglected area of medical practice and further research is needed to identify all women who will benefit from it since studies in menopausal women have shown parenteral administration to be well tolerated and safe. Such therapy is underused and very much underresearched. While testosterone implants work adequately, it would be more desirable and convenient to use a testosterone patch and safer, more effective oral androgens, if these products were available.

Androgens↗
PubMed1993

Type III collagen content in the skin of postmenopausal women receiving oestradiol and testosterone implants.

OBJECTIVE: To investigate the effect of subcutaneous oestradiol and testosterone on the proportion of type III collagen in the skin of postmenopausal women. DESIGN: A cross sectional comparison. SETTING: Dulwich Hospital menopause clinic. SUBJECTS: Fourteen untreated women and 11 women who had received subcutaneous oestradiol and testosterone for a median 8.0 years (range 3-14). Ten of the untreated women received subcutaneous hormone implants and the effect on skin collagen was studied prospectively. MEASUREMENTS: The proportion of type III collagen in skin biopsies taken from the lateral aspect of the thigh. RESULTS: The median type III collagen content in the skin of the women who had received hormone replacement therapy (25.4%, range 21.4-30.2) was significantly higher (P < 0.01) than in the untreated women (19.6%, range 18.2-28.8). The proportion of type III collagen in the skin of 10 untreated women increased significantly (P < 0.01) from a median of 19.9% (range 18.2-23.9) to 22.4% (range 20.5-31.5) following 6 months of treatment with hormone implants. CONCLUSION: This study indicates an increase in the proportion of type III collagen in women receiving hormone replacement therapy.

Adult↗
PubMed1992

Comparison of attitudes of donors and recipients to oocyte donation.

The attitudes of volunteer donors and recipients undergoing treatment in an ovum donation programme were studied in order to assess both the psychological and psycho-social aspects of the procedure. A questionnaire was sent to 35 donors and 60 recipients. All donations were unpaid. Fifty-eight were anonymous donations and three were known. Eighty-six per cent of recipients and 74% of donors had told at least one person other than their partner. Eighty per cent of donors and 66% of recipients agreed that donors should not be paid. Sixty-three per cent of donors would donate if the recipient was told their name but only 26% of recipients would accept if the donor was given their name. Seventy per cent of the donors would donate to someone they knew but would rather donate anonymously. Ninety per cent of recipients were strongly against the donor contacting the child later in life but 54% of donors had no objection to the child contacting them. Eighty-six per cent of recipients and 56% of donors felt that if they had been born from a donated oocyte, they would not want to know.

Female↗
PubMed1992

MD madness.

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Clinical Competence↗
PubMed1992

The effects of plasma estradiol levels on increases in vertebral and femoral bone density following therapy with estradiol and estradiol with testosterone implants.

Percutaneous estradiol (E2) implants effectively preserve bone density in postmenopausal women. However, these implants are often given with testosterone, which may itself have an anabolic effect on bone. To determine whether testosterone confers any additional bone-sparing effect, we studied 50 postmenopausal women randomly allocated to receive E2 (75 mg) alone or with testosterone (100 mg) every 6 months for 1 year. Women with an intact uterus received cyclic norethindrone (5 mg) for 10 days of each calendar month. Twenty-five untreated women were recruited to act as a reference group. Bone density was measured at the lumbar spine and proximal femur by dual x-ray densitometry. By 1 year, bone density at the lumbar spine had fallen by 1.8% in the reference group. In the women treated with E2 alone, it increased significantly by 7.8% (P less than .0001) and in those receiving E2 with testosterone, it increased by 6.3% (P less than .0001). At the femoral neck, bone density decreased by 3% in the controls and increased by approximately 4% in both treated groups (P less than .0001). The increase in bone density at these sites was unrelated to the woman's chronological age, menopausal age, or initial bone density. However, it correlated significantly with the serum E2 levels attained after 1 year of therapy. In no treated patients did bone density decrease significantly. These data show that testosterone confers no additional bone-sparing effect in postmenopausal women.

Bone Density↗