The presentations will focus on recently completed studies designed to determine drug concentration and release characteristics for DARE-HRT1 and DARE-FRT1, novel intravaginal ring drug delivery product candidates containing bio-identical hormones being developed for the treatment of menopause-related vasomotor symptoms and luteal phase
pregnancy maintenance, respectively.
On the other hand, the data showed that the duration and range of the luteal phase
- the latter part of the menstrual cycle - matched previous studies.
This may be mainly due to the normal hormonal disturbances that occur during the late luteal phase
of the menstrual cycle.
Therefore, a progesterone supplement is administered during the luteal phase
to achieve optimal endometrial receptivity (4).
So far, very few studies monitored the relation of sexual ovary hormones in the late luteal phase
, most often in the first 7 days after ovulation.
The product is indicated for luteal phase
support during in-vitro fertilisation cycles.
that for patients undergoing IVF-ET/ICSI with luteal support, although the VP group showed a lower serum progesterone level, it exhibited a significantly higher implantation rate and ongoing pregnancy rate compared to the IMP group. Progesterone administrated through vagina can be locally absorbed by cervical cells, and rapidly transported to the endometrial cells, thereby achieving a high progestogen concentration in the uterine cavity and preferable conditions for implantation of embryos. The histochemical analyses of endometrial biopsy found that progestogen concentration in endometrial cells inpatients of the VP group was significantly higher than that in IMP patients and the luteal phase
concentration in untreated patients.
This short-term feeding stage is a critical period in the luteal phase
of the estrous cycle (Somchit et al., 2007) or during the 6-day period before functional luteolysis (King et al., 2010).
The diagnosis of luteal phase
defect was made by using Jones criteria.
The study was performed in a sample of 17 healthy women volunteers of reproductive age (mean 34.2 [+ or -] 4.7 years in luteal phase
and mean 36.7 [+ or -] 4.5 years in follicular phase) and in 11 postmenopausal women (mean 53.9 [+ or -] 7.3 years).
Whilst the exact mechanism of cyclical mastalgia is not known, its timing in the luteal phase
suggests a hormonal component.
Autoimmune progesterone dermatitis (AIPD) is a rare autoimmune response to endogenous progesterone, characterized by cyclic cutaneous and mucosal lesions at the end of the luteal phase
with varied type of skin lesions include urticaria, angioedema, erythema multiforme, eczema, folliculitis, papulovesicular eruptions, fixed drug eruption, purpura, or vulvovaginal pruritus and anaphylaxis.