Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, GnRH antagonist, LH, androgen, testosterone
Brief summary
The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.
Interventions
DRUGGanirelix
An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.0625 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.
Sponsors
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Minimum weight of 51 kg * BMI between 20 and 25 * women with PCOS with AMH\> 28 pmol / L, LH\> 8 IU / mL and testosteronemia \> 0.39 ng/mL * no hormonal treatment or contraception for 2 months * women covered by the Social Security system
Exclusion criteria
* hormonal treatment or hormonal contraception * Metformin treatment * pregnant woman * inability to understand the newsletter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum LH level | every 10 minutes for 8 hours | The degree of gonadotropin suppression will be determined by calculating the percent inhibition from the pre-antagonist period \[(mean PRE - nadir)/mean PRE\] x 100, where nadir hormone levels will be calculated using a moving average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve) | at the beginning and at the end of the 8 hours | — |
| Variation in androgen production | at 4 hours after injection | defined by the difference between the measurement at H8 and the measurement at H0 (4 hours before injection) of total testosterone and androstenedione. |
| change in FSH levels | at 4 hours post-injection | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of FSH |
| change in estradiol levels | at 4 hours post-injection | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of estradiol |
| change in AMH levels | at 4 hours post-injection | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of AMH. |
Countries
France
Outcome results
None listed