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Biomedical subjects

O Chevallier

Publications and source records attributed to O Chevallier.

5 recordsLinked to original sources
PubMed2002

Efficacy and tolerability of pulsed estrogen therapy: a 12-week double-blind placebo-controlled study in highly symptomatic postmenopausal women.

OBJECTIVE: To confirm the efficacy and safety of pulsed estrogen therapy, a transient daily hormone exposure, for climacteric symptoms in highly symptomatic postmenopausal women. PATIENTS AND METHODS: In this multicenter, double-blind, parallel-group study, early postmenopausal women with at least seven moderate to severe vasomotor symptoms per day were randomized to receive intranasal estradiol, 150 or 300 microg/day, or placebo, for 12 weeks. The primary outcome measure was the mean daily number of moderate to severe vasomotor symptoms, as recorded in patient diaries. RESULTS: A total of 165 patients were randomized. The mean daily number of moderate to severe vasomotor symptoms decreased significantly more (p < 0.001) in the 150-microg/day (-7.86) and 300-microg/day (-9.39) groups than in the placebo group (-5.22). The decrease reached significance more rapidly with the 300-microg/day dose (from week 2) than with the 150-microg/day dose (from week 8). The rate of emergent adverse events with both doses was similar to that with placebo. CONCLUSIONS: Pulsed estrogen therapy, achieved by intranasal estradiol 150 microg/day and 300 microg/day, significantlyreduced the incidence of moderate to severe vasomotor symptoms, compared with placebo. The 300-microg/day dose demonstrated a greater and more rapid therapeutic effect, with no clinically significant difference in tolerability, compared with the 150-microg/day dose, and therefore offers the best efficacy/safety ratio when initiating treatment with intranasal estradiol.

Administration, Intranasal↗
PubMed2000

Clinical equivalence of intranasal and oral 17beta-estradiol for postmenopausal symptoms.

OBJECTIVE: The aim of this study was to demonstrate clinical equivalence between a novel intranasal estradiol formulation and a reference oral drug. STUDY DESIGN: In this multinational, double-blind, parallel-group study 659 postmenopausal women with moderate to severe postmenopausal symptoms were randomly assigned to receive either 300 microg/d intranasal 17beta-estradiol (S21400) or 2 mg/d oral micronized estradiol, plus the appropriate placebo, for 24 weeks. All patients also received 10 mg/d dydrogesterone for 14 days per 28-day cycle. Adjustment of intranasal dosage was permitted from week 14 on. The primary efficacy criterion was the Kupperman index at week 14, with a predefined limit of equivalence of 4. RESULTS: Kupperman index scores improved similarly in the 2 groups, from 28.4 +/- 6.2 to 10.0 +/- 8.6 (mean +/- SD) for S21400 and from 28.1 +/- 6.0 to 8.9 +/- 8.0 for oral therapy, with a difference between groups at week 14 of 1.1 +/- 0.6 (90% confidence interval, 0. 0 to 2.2). This was below the predefined equivalence limit of +4 for statistical noninferiority (P <.001). The daily number and intensity of hot flushes decreased similarly in the two treatment groups. Withdrawal bleeding was 20% less frequent with intranasal therapy (90% confidence interval, 12.5 to 27.6). Severe mastalgia was less frequent in the S21400 group (1.0%) than in the group with oral therapy (5.2%; P <.01). Triglyceride and angiotensinogen levels increased significantly with oral therapy but not with S21400. The same number of patients required dose adaptation in the 2 groups (approximately 20%). CONCLUSION: Intranasal administration of 300 microg/d estradiol was at least as effective as oral administration of 2 mg/d estradiol in alleviating postmenopausal symptoms, with less frequent mastalgia and uterine bleeding and without the metabolic consequences of the first-pass effect.

Administration, Intranasal↗
PubMed1988

A new in vitro fertilization technique: intravaginal culture.

Intravaginal culture (IVC) is a new technique elaborated by the authors for the fertilization and culture of human oocytes. Its principle consists of fertilization and early development of the eggs in a closed, air-free milieu without the addition of CO2. One to five ovocytes are deposited in a tube completely filled with 3 ml of culture medium less than 1 hour after their recovery, with 10,000 to 20,000 spermatozoa per ml previously prepared. The tube is then hermetically closed and it is placed in the maternal vagina and held by a diaphragm for incubation for 44 to 50 hours. After this time, the content of the tube is examined and embryos are transferred to the uterus. In the first 100 consecutive punctures, 22 clinical pregnancies were obtained: 17 deliveries, 3 spontaneous abortions, and 2 tubal pregnancies. Also, a randomized study comparing IVC to in vitro fertilization (IVF) was done (160 cycles) and no statistically different cleavage, transfer, or pregnancy rate was seen between IVC and IVF. By simplifying the laboratory manipulations, this technique decreases the cost of IVF and permits its standardization and diffusion. It creates a psychologic comfort permitting active participation of the mother in this stage of embryo development. Also, the use of this technique may give greater knowledge of human gamete metabolism and of the physiology of reproduction.

Adult↗
PubMed1988

[Intravaginal culture and embryo transfer].

The intra-vaginal culture and embryo transfer is based on the principle of fertilization of hyman ovocytes in the absence of CO2-enriched air. Ovocytes and spermatozoa are placed in a water-tight tube filled with B2 medium and placed in the vagina during the culture. Once the culture is done, the embryos are replaced in the uterus. The various studies done with intra-vaginal culture and embryo transfer, their results as well as future prospects are reviewed in detail.

Cells, Cultured↗