NEWS HIGHLIGHTS
Published Studies Related to Synarel (Nafarelin Nasal)
A randomized, parallel, comparative study of the efficacy and safety of nafarelin versus danazol in the treatment of endometriosis in Taiwan. [2005.07]
BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of nafarelin, a gonadotropin-releasing hormone (GnRH) analogue, versus danazol in the treatment of women with endometriosis in Taiwan... CONCLUSION: Nafarelin and danazol demonstrated similar clinical efficacy, but nafarelin was associated with fewer laboratory changes and a stable lipid profile, relative to danazol. Moreover, intranasally administered nafarelin is noninvasive, and may be a more comfortable and safer alternative to slow-release injectable GnRH agonists. Based on this study, we suggest that nafarelin, like other GnRH analogues, may be a treatment of choice for Taiwanese women with endometriosis. However, direct comparative studies of nafarelin with slow-release injectable GnRH agonists are now required.
Reversible downregulation of endocrine and germinative testicular function (hormonal castration) in the dog with the GnRH-agonist azagly-nafarelin as a removable implant "Gonazon"; a preclinical trial. [2009.04.15]
Downregulation of anterior pituitary GnRH-receptors by application of a slow release GnRH-implant offers an effective and reversible alternative to surgical castration of the male dog. Aim of the present study was to test the efficacy and the underlying mechanisms of a new non-biodegradable controlled-release device implant (Gonazon((R)), Intervet, containing 18.5mg of the GnRH-agonist Azagly-Nafarelin).
Clinical Trials Related to Synarel (Nafarelin Nasal)
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment [Not yet recruiting]
Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh
IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be
replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where
the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement
Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT − FER).
Both are widely used methods of fertility treatment. However, to date no well designed
studies have been reported in which the two methods have been compared. This study aims to
compare the two treatments in order to establish the best treatment protocol.
The study design is a single centre open randomized controlled trial funded by the Oxford
Fertility Unit.
100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible
for the study will be recruited.
After giving their written consent they will be randomised to one of 2 groups: Natural FER
and HRT FER.
Patients in both groups will be asked to attend one initial visit, which is additional to
patients not taking part in the study.
Subsequent visits will depend on the treatment group but will not be additional for study
participants. All visits requiring ultrasound will involve recording 3âD measurements, which
increases the length of each visit by approximately 10 minutes. A patient satisfaction
questionnaire would be completed at the end of the cycle.
A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit.
If this is positive then further visits to the unit are arranged to confirm the clinical
pregnancy.
Inclusion in the study would not increase the length of time of either treatment cycle.
Follow up would extend to obtaining pregnancy outcome information.
Endometriosis : Traditional Medicine vs Hormone Therapy [Completed]
This 36-week study will determine whether traditional Chinese medicine (acupuncture and
Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related
pelvic pain.
Short Versus Long Protocol for IVF and IVF+ICSI [Recruiting]
Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to
1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
2. quality of life (2. outcome measure)
3. live birth rate (2. outcome measure)
4. gene expression profiles of granulosa and cumulus cells, and concentrations of
estradiol and vascular endothelial growth factor in follicular fluid(not only compared
between GnRH agonist and antagonist protocol, but also between patients with OHSS and
no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure),
and
5. number of oocytes removed per treatment, number of embryo transfers per treatment and
number of spontaneous abortions per treatment (these three parameters are tertiary
outcome measures).
In addition to the above mentioned efficacy outcome measures the safety outcome measure
"frequency of known side-effects" will be compared between the two protocols.
Reports of Suspected Synarel (Nafarelin Nasal) Side Effects
Respiratory Distress (3),
Cerebral Infarction (3),
Uterine Haemorrhage (3),
Endometrial Hyperplasia (2),
Vascular Dissection (2),
Visual Impairment (2),
Endometrial Atrophy (2),
Drug Ineffective (1),
Osteoporosis (1),
Pain (1), more >>
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