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C Pelissier

Publications and source records attributed to C Pelissier.

At least 19 recordsLinked to original sources
PubMed2003

Changes in body composition during post-menopausal hormone therapy: a 2 year prospective study.

BACKGROUND: Post-menopausal hormone therapy (pHT) induces changes in both body composition and bone mineral density (BMD). METHODS: In 109 post-menopausal women beginning either tibolone 2.5 mg (n=29), tibolone 1.25 mg (n=42) or estradiol 2 mg plus norethisterone acetate 1 mg (E2 + NETA) (n=38), we assessed body composition, total and regional BMD by dual energy X-ray absorptiometry, and the serum bone alkaline phosphatase (BAP), osteocalcin and the urinary excretion to type I collagen C-telopeptide (CTX) at baseline and after 2 years. RESULTS: At baseline, BMD at all sites correlated negatively with age and years since menopause, and positively with lean mass and fat mass (r=0.42, P<0.001 and r=0.26, P=0.006 at the total femur). During treatment, BMD increased at all sites (P<0.001), and serum BAP, osteocalcin, and urinary CTX decreased in all groups (P<0.001). Lean mass increased whereas android fat and android obesity index decreased. The increase in BMD at all sites correlated positively with changes of lean mass at 2 years. CONCLUSIONS: Both fat mass and lean mass are related to BMD in post-menopausal women, the relationship being strongest with lean mass; an increase in lean mass and a change in distribution of body fat are observed during treatment with E2 + NETA and tibolone.

Adipose Tissue↗
PubMed2002

Randomized, double-masked, 2-year comparison of tibolone with 17beta-estradiol and norethindrone acetate in preventing postmenopausal bone loss.

In this 2-year, randomized study, we compared the efficacy and tolerability of tibolone 2.5 mg (n = 75), tibolone 1.25 mg (n = 76) and estradiol 2 mg plus norethindrone acetate 1 mg (E2/NETA: n = 74) for preventing bone loss in postmenopausal women. Bone mineral density (BMD), measured by dual-energy X-ray absorptiometry, and bone remodeling markers were assessed every 6 months. Side-effects were assessed quarterly. After 24 months, the mean increase (+/- SD) in lumbar spine BMD from baseline was 3.6% +/- 2.9%, 1.9% +/- 3.5% and 6.8% +/- 4.5% in the tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA groups, respectively. All pairwise differences were significant. The proportion of responders (women with a change from baseline in lumbar spine BMD of > or = -2% after 2 years) was 95.7%, 89.0% and 98.5% with tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA, respectively. Similar results were obtained for femoral BMD, although the difference between tibolone 2.5 mg and E2/NETA was not significant at 24 months. Decreases in bone remodeling markers were similar in the three groups. Vaginal bleeding was more common in the E2/ NETA group (33.8%) than with tibolone 2.5 mg (12.0%) or tibolone 1.25 mg (9.2%), as was breast pain (23.0%, 2.7% and 2.6%, respectively). Each treatment effectively prevented bone loss. Overall, tolerability of tibolone was better than with E2/NETA, because of less frequent vaginal bleeding and breast pain. This may promote long-term adherence.

Androgen Antagonists↗
PubMed2001

Dose-ranging studies of a novel intranasal estrogen replacement therapy.

OBJECTIVE: To study the efficacy and tolerability of Aerodiol, a novel intranasal estradiol spray, and to determine an appropriate dose range. METHODS: An exploratory, parallel-group, dose-finding study was followed by a large-scale, double-blind, placebo-controlled study. In the exploratory study, 134 postmenopausal women were allocated to receive a daily dose of 100--900 microg of Aerodiol for 12 weeks. Efficacy was determined by an overall assessment of estrogenization. In the placebo-controlled study, 420 postmenopausal women were randomized to receive 100, 200, 300, or 400 microg of Aerodiol, or oral estradiol 1 or 2 mg, or placebo, daily for 12 weeks. Efficacy was assessed by the Kupperman Index and the number of hot flushes per day after 12 weeks. RESULTS: In the exploratory study, the level of estrogenization was sufficient for 23% of women in the 100 microg/day group, excessive for 36% of the 900 microg/day group, and good for more than 80% of women receiving 200--600 microg/day. In the placebo-controlled study, the Kupperman Index at week 12 was significantly lower than placebo (P<0.01) for all Aerodiol groups except the 100 microg/day group. The efficacy of Aerodiol 300 microg/day was similar to oral estradiol 2 mg/day. The variability in exposure to estradiol was lower with Aerodiol than with oral estradiol. Aerodiol therapy was well tolerated in both studies. Premature withdrawals were approximately equally distributed among treatment groups in the placebo-controlled study. CONCLUSIONS: Aerodiol was effective in reducing climateric symptoms at doses between 100 and 600 microg/day. Treatment was well tolerated and well accepted. A dose of 300 microg/day is recommended for initiating hormone replacement therapy.

Administration, Intranasal↗
PubMed2001

Clinical evaluation, dose-finding and acceptability of AERODIOL, the pulsed estrogen therapy for treatment of climacteric symptoms.

S21400 (AERODIOL) is a new intranasal formulation of 17beta-estradiol. It provides a pulsed estrogen therapy that ensures sufficient estrogenisation of tissues to treat estrogen deficiency symptoms, particularly those of the menopause. This multicentric study was designed to determine dose-range, efficacy and acceptability of S21400. One hundred and thirty four women were allocated a daily dose of 100-900 microg for 12 weeks. The doses of 100, 600 and 900 microg were given in two daily administrations, the doses of 200, 300 and 450 microg were given in one and two daily administrations. Oral progestogen was added the last 10-14 days of each cycle of estrogen therapy in all non-hysterectomized women. S21400 showed a dose-effect relationship and provided adequate estrogenisation in more than 80% of patients receiving a dose ranging from 200 to 600 microg daily. Hormonal impregnation was judged sufficient in 23% of women receiving the lowest dose (100 microg). It was often considered excessive for daily doses of 900 microg (36%). After 12 weeks of treatment, efficacy was similar whether the total daily dose was given in one or two administrations. Treatment was well tolerated and accepted, with only minor nasal events (prickling, sneezing). It was perceived by 92% of patients as good or excellent and 81% chose to continue the nasal treatment when it was offered to them. An initial dose of 300 microg per day provides an optimal efficacy/tolerability ratio. In summary, the pulsed estrogen therapy with AERODIOL in one daily administration offers a safe, well accepted and highly effective treatment to alleviate climacteric symptoms. It can be adapted easily to ensure optimal clinical efficacy.

Administration, Inhalation↗
PubMed1999

Effects of intranasal 17beta-estradiol on bone turnover and serum insulin-like growth factor I in postmenopausal women.

Estrogen therapy, using either oral or transdermal routes, decreases bone turnover and prevents postmenopausal bone loss. It has been suggested that oral and transdermal 17beta-estradiol (E2) may have different effects on serum insulin-like growth factor I (IGF-I), a potent bone-forming growth factor. In this study we investigated the effects of a new route of administration, the intranasal E2 spray (S21400), on bone turnover and circulating IGF-I and IGF-binding protein-3 (IGFBP-3). Four hundred and twenty early postmenopausal women (<5 yr since menopause; mean age, 52 yr) were enrolled in a 3-month, double blind, placebo-controlled study of four doses of intranasal E2 (100, 200, 300, and 400 microg/day), two doses of oral E2 valerate (1 or 2 mg/day), and placebo. One hundred and twelve women were further treated for 12 months with intranasal E2 (300 microg/day, i.e. the dose that has been shown to be adequate for the majority of postmenopausal women). Markers of bone resorption (urinary type I collagen C telopeptides) and formation [serum osteocalcin, serum type I collagen N-terminal extension propeptide (PINP), and serum bone alkaline phosphatase (BAP)] were measured at baseline, 1 month, 3 months, and 15 months. Serum IGF-I and IGFBP-3 were measured at baseline, 1 month, and 3 months. Urinary type I collagen C telopeptides decreased significantly in all active treatment groups as soon as 1 month (P<0.001 vs. placebo) and continued to decrease at 3 months with a dose effect for intranasal E2. Serum osteocalcin and PINP did not change at 1 month for oral E2 (1 and 2 mg), but decreased significantly at 3 months. In contrast, formation markers increased significantly at 1 month for the two highest doses of intranasal E2 (P<0.01 vs. placebo for osteocalcin and BAP) and did not decrease at 3 months. Oral E2 induced a marked decrease in circulating IGF-I as early as 1 month, which was amplified at 3 months (-29% and -32% for 1 and 2 mg, respectively), whereas no significant change from placebo was observed for intranasal E2 during the 3-month period. Changes in circulating IGF-I correlated significantly (P<0.01) with changes in osteocalcin, PINP, and BAP at 3 months. Oral and intranasal E2 did not induce any significant change from placebo in serum IGFBP-3 at both 1 and 3 months. After 1 yr of treatment with intranasal E2 (300 microg/day), both resorption and formation markers decreased, reaching the levels in premenopausal women, regardless of the type of treatment during the first 3 months. We conclude that E2 administered by this new nasal route normalizes bone turnover to premenopausal levels. The delayed decrease in bone formation observed with intranasal E2 compared to oral E2 may be related to different effects on serum IGF-I levels.

Administration, Intranasal↗
PubMed1997

Fibrinogen and plasminogen modifications during oral estradiol replacement therapy.

OBJECTIVE: To assess the effects of oral E2 replacement therapy on various hemostatic parameters and cardiovascular risk factors in healthy, postmenopausal women. DESIGN: A double-blind, randomized, prospective study comparing the effect of a placebo and of oral micronized E2 (2 mg daily) during a 6-month period. Evaluations were performed before treatment and after 3 and 6 months. SETTING: Departments of Gynecology, Hemostasis, and Nutrition, Hôtel-Dieu, Paris, France. PATIENT(S): Thirty-six healthy women with natural or surgical menopause. RESULT(S): Compared with placebo, oral E2 replacement therapy resulted in a significant decrease in fibrinogen and apo B and a significant increase in plasminogen. CONCLUSION(S): Besides the effects on lipoproteins, oral estrogen replacement therapy modifies parameters involved in coagulation and fibrinolysis.

Administration, Oral↗
PubMed1995

Bone loss during gonadotropin releasing hormone agonist treatment and use of nasal calcitonin.

Gonadotropin releasing hormone (GnRH) agonists have shown to be effective in the treatment of several sex-hormone-dependent conditions. However, their use could be limited by the bone loss they induce. To evaluate the use of nasal salmon calcitonin (sCT) in preventing this bone loss, 40 patients with endometriosis were treated for 6 months with triptoreline (3.75 mg monthly) and calcium (1 g daily), and randomized in three groups-placebo, sCT 100 IU daily and sCT 200 IU daily-in a prospective double-masked study. Dual-energy X-ray absorptiometry and biochemical parameters were used to evaluate the benefit of the treatment. At baseline, there were no statistically significant differences between the groups. After 6 months, estradiol and biochemical markers of bone metabolism were at postmenopausal levels, with no difference between the groups. There was no difference in bone loss in the three groups, at all sites. Mean lumbar bone loss was 4.01 +/- 2.59% (mean +/- SD) in this population. In this study dosages of 100 IU and 200 IU daily of nasal sCT were insufficient to prevent bone loss during GnRH agonist treatment.

Absorptiometry, Photon↗
PubMed1995

A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance.

The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation.

Adolescent↗
PubMed1994

[Antiovulatory action of chlormadinone acetate].

Antiovulatory action of chlormadinone acetate (5 mg twice daily from day 7 to day 25) has been assessed in 6 healthy volunteers by daily determination of plasma FSH, LH, estradiol and progesterone. Hormonal profiles during the second treated cycle show that preovulatory gonadotropin surge is blunted and that no significant progesterone secretion occurs. Estradiol production is variable up to the middle of the cycle, and then homogeneously low normal. Menstrual cyclicity is respected and ovarian function is restored during the first cycle after treatment disruption.

Adult↗
PubMed1994

Full-term pregnancy with embryos from donated oocytes in a 36-year-old woman allografted for chronic myeloid leukemia.

We report the first case of full-term pregnancy arising from donated oocytes in a 36-year-old woman with chronic myeloid leukemia (CML), 6 years after allogeneic bone marrow transplantation (BMT) following total body irradiation (TBI) (12 Gy) and cyclophosphamide 120 mg/kg. The first attempt at implantation with her own cryopreserved ovocytes was unsuccessful. Thereafter, she became pregnant after donated oocyte implantation using estradiol and progesterone support replacing the defective ovarian function. The baby was normal. Unfortunately, 6 months later, she relapsed in chronic phase of CML.

Adult↗
PubMed1993

Hemostatic and metabolic effects of lowering the ethinyl-estradiol dose from 30 mcg to 20 mcg in oral contraceptives containing desogestrel.

The metabolic and hemostatic effects of two oral contraceptives containing 150 mcg desogestrel and 20 mcg ethinyl-estradiol (EE) (MERCILON) or 30 mcg EE (MARVELON) were compared in order to examine the effect of reducing the EE dose in contraceptive pills. Forty-nine women participated in this randomized study during 6 cycles. In both groups, there was a significant increase in triglycerides, HDL-cholesterol and apoprotein A1; the same increase was observed for SBP and CBG. Slight and transient variations of fasting blood glucose levels were seen in the 30 mcg EE group and in the two groups for fasting insulin levels. The increase in renin substrate was significantly higher with the 30 mcg EE than with the 20 mcg EE pill. In both groups, plasminogen increased significantly, but antithrombin III, total and free protein S and fibrinogen decreased significantly only in women taking the 30 mcg EE pill, whereas there was no significant change in the 20 mcg EE group. Reducing the dose of EE in oral contraceptives from 30 mcg to 20 mcg minimizes their impact on renin substrate and hemostatic parameters.

Apolipoprotein A-I↗
PubMed1991

Effects of nomegestrol acetate (5 mg/d) on hormonal, metabolic and hemostatic parameters in premenopausal women.

The effects of nomegestrol acetate on circulating hormone levels, metabolic and hemostatic parameters and blood pressure were studied in 36 premenopausal women. The progestogen was administered from day 7 to 25 of the cycle during six cycles at a dosage (5 mg/d) known to inhibit ovulation. Analysis were performed before and in the third and sixth cycles. Estradiol and progesterone levels decreased significantly (p less than 0.001) during treatment. Body weight, fasting blood glucose and insulin, total HDL and LDL cholesterol, apolipoprotein B, fibrinogen and plasminogen did not change significantly. Triglycerides in the third cycle (p less than 0.05) and apolipoprotein A1 levels (p less than 0.01) in both periods of sampling decreased significantly. There was a significant increase in antithrombin III (p less than 0.01). These results indicate that nomegestrol acetate has no deleterious effect on blood glucose and lipids. The decrease in apolipoprotein A1 and increase in antithrombin III may be related either to the decrease in estradiol levels induced by the treatment or to the effect of the progestogen itself.

Adolescent↗
PubMed1990

[Hormonal contraception and lupus].

The choice of an optimal contraceptive method (OC) therapy is a significant problem in female SLE patients. In view of the influence of sex hormones on the evolution of SLE, oral contraceptive (OC) therapy has to be efficient, reversible and safe, without aggravating disease activity and causing metabolic and vascular side effects. Ethinyl estradiol-containing preparations, even at 30 micrograms/day, have been shown to trigger a crisis or unmask SLE, and they exert adverse metabolic and vascular effects. Therefore, combination estrogen-progestogen compounds must be avoided in women with SLE. Pure progestogen OC preparations do not stimulate SLE activity, but norsteroids have harmful metabolic effects and microprogestogens are not sufficiently reliable. In light of the decreased level of plasma androgens in female SLE patients, an attempt to modulate the hormonal milieu by lowering the estrogen to androgen ratio, while ensuring contraception was attempted using cyproterone acetate. This agent markedly lowered plasma estrogens and was effective and well tolerated, but its long-term effect on bone mineralization remains to be evaluated. Chlormadinone acetate, a 17-OH progesterone derivative, was proven effective and devoid of any metabolic or vascular side effects, and should be recommended as the safest routine OC therapy in women with SLE.

Chlormadinone Acetate↗
PubMed1990

[Anti-angina effect of amiodarone versus delayed-action propranolol. A double-blind randomized study].

Long-acting Propranolol (160 mg/day) and Amiodarone (200 mg/day after impregnation) were compared in chronic stable angina pectoris. Forty-three patients with stable angina of effort were included in a randomised double blind trial (19 in the amiodarone and 24 in the propranolol group). The duration of the study was 8 weeks; the placebo phase (2 weeks) was followed by 6 weeks of active treatment. An exercise stress test was performed before and after the treatment period. The number of episodes of angina and the consumption of glyceryl trinitrate decreased significantly (p less than 0.001) in the same proportion with both drugs with respect to the placebo period. The time to the appearance of criteria of positivity of the exercise stress test increased from 6.82 +/- 0.50 mn to 8.35 +/- 0.50 mn with amiodarone, and from 7.15 +/- 0.47 mn to 9.50 +/- 0.52 with the propranolol preparation. This improvement was very significant compared with the placebo phase (p less than 0.001) but the difference between the two drugs was not statistically significant (p = 0.39). The other parameters which were studied (time to onset of angina, total duration of exercise, maximum heart rate, double product, maximum ST depression) changed in a parallel fashion significantly versus placebo. There were no differences between the two treatment groups with the exception of the resting heart rate which decreased more in patients on propranolol (80.94 +/- 3.92 to 62.47 +/- 1.97) than in patients on amiodarone (84.87 +/- 2.63 to 73.41 +/- 2.01; p less than 0.0005).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

Comparative metabolic study of percutaneous versus oral micronized 17 beta-oestradiol in replacement therapy.

The aim of this study was to compare the metabolic effects of two presentations of 17 beta-oestradiol (E2) which are of recognized effectiveness in the prevention of post-menopausal bone loss, one being administered via the oral and the other via the percutaneous route. During this prospective, randomized study, 32 patients were treated for 2 mth with either 2 mg/day of oral micronized E2 (n = 16) or 1.5-3 mg/day of percutaneous E2 (n = 16). Both regimens proved efficacious, since significant increases in oestrone (E1) and E2 concentrations ranging up to mid-follicular values were observed. In the percutaneous-treatment group we noted a significant decrease in triglycerides (TG), without any significant changes in high-density lipoprotein cholesterol (HDL-C) or low-density lipoprotein cholesterol (LDL-C). In the oral-treatment group, we saw no significant increase in HDL-C, although significant increases were observed in body weight, TG, plasma renin substrate (PRS) and sex-hormone-binding globulin (SHBG) as well as significant decreases in antithrombin III (AT III) activity and antigen. All of these metabolic variations led us to the conclusion that oral E2 at the dose established as effective in preventing post-menopausal osteoporosis may, even when micronized, alter certain metabolic and haemostatic parameters in a population characterized by increases in cardiovascular risk factors and morbidity. Oral oestrogen replacement therapy should therefore continue to be used only in carefully selected patients and be strictly followed up by systematic checks on a series of metabolic criteria.

Administration, Cutaneous↗
PubMed1989

[Herpetic manifestations: diagnosis, treatment, prevention].

Herpes virus infection is an extremely common disease that affects between 90 to 100% of the population above the age of 15. The authors propose studying successively the clinical and virological diagnosis of this infection, it's treatment, and finally it's prevention in the dental clinic where there is a large possibility of transmitting the infective diseases.

Dentists↗