Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507332
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone for Ovulation Induction in Women With Polycystic Ovary Syndrome A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clomiphene citrate is a non-steroidal triphenylethylene derivative distantly related to diethylstilbestrol It acts as a selective estrogen receptor modulator SERM similar to tamoxifen and raloxifene All three drugs are competitive inhibitors of estrogen binding to estrogen receptors ERs and have mixed agonist and antagonist activity depending upon the target tissue
Letrozole is a potent nonsteroidal aromatase inhibitor originally used for postmenopausal breast cancer therapy
Letrozole is a potent nonsteroidal aromatase inhibitor originally used for postmenopausal breast cancer therapy
Detailed Description:
Polycystic ovary syndrome PCOS is the most common endocrine disorder in reproductive-age women and the most common cause of anovulatory infertility The treatment of infertility in patients with PCOS focuses on ovulation induction Many treatment regimens have been used with varying success to achieve ovulation pregnancy and live birth
Clomiphene citrate CC is a commonly prescribed pharmacologic agent used to induce ovulation in women with PCOS It works as a selective estrogen receptor modulator by competitively attaching to nuclear estrogen receptors As the negative feedback of estrogen is reduced secretion of gonadotropin hormones increases inducing ovarian follicular growth
Clomiphene citrate CC also has an anti-estrogenic effect on endometrial development and cervical mucus productionwhich has been suggested to contribute to a relatively low pregnancy rate despite a high ovulation rate
Letrozole is another commonly used oral ovulation induction agent with a different mechanism of action It works as a highly selective aromatase inhibitor preventing androgen-to-estrogen conversion One proposed mechanism is via suppressed estrogen production resulting in decreased negative feedback on the hypothalamus and increased secretion of Follicular Stimulating Hormone FSH An additional proposed mechanism of improved ovulatory rates with the use of letrozole is increased follicular sensitivity to FSH resulting from temporarily increased intraovarian androgens
Letrozole may offer a benefit over CC for ovulation induction because it does not block estrogen receptors in both central and peripheral target tissues and normal central feedback mechanisms remain intact The Pregnancy and Polycystic Ovary Syndrome PPCOS trial a randomized controlled trial comparing letrozole and CC demonstrated that letrozole was associated with a higher live birth rate 275 vs 191 P007 rate ratio 144 95 confidence interval CI 110-187 and cumulative ovulation rate 617 vs 483 P001 among women with PCOS
Other than letrozole or CC for ovulation induction there are few treatment options available to PCOS patients except proceeding to gonadotropin injections or in vitro fertilization both of which are associated with increased cost and risk
Clomiphene citrate CC is a commonly prescribed pharmacologic agent used to induce ovulation in women with PCOS It works as a selective estrogen receptor modulator by competitively attaching to nuclear estrogen receptors As the negative feedback of estrogen is reduced secretion of gonadotropin hormones increases inducing ovarian follicular growth
Clomiphene citrate CC also has an anti-estrogenic effect on endometrial development and cervical mucus productionwhich has been suggested to contribute to a relatively low pregnancy rate despite a high ovulation rate
Letrozole is another commonly used oral ovulation induction agent with a different mechanism of action It works as a highly selective aromatase inhibitor preventing androgen-to-estrogen conversion One proposed mechanism is via suppressed estrogen production resulting in decreased negative feedback on the hypothalamus and increased secretion of Follicular Stimulating Hormone FSH An additional proposed mechanism of improved ovulatory rates with the use of letrozole is increased follicular sensitivity to FSH resulting from temporarily increased intraovarian androgens
Letrozole may offer a benefit over CC for ovulation induction because it does not block estrogen receptors in both central and peripheral target tissues and normal central feedback mechanisms remain intact The Pregnancy and Polycystic Ovary Syndrome PPCOS trial a randomized controlled trial comparing letrozole and CC demonstrated that letrozole was associated with a higher live birth rate 275 vs 191 P007 rate ratio 144 95 confidence interval CI 110-187 and cumulative ovulation rate 617 vs 483 P001 among women with PCOS
Other than letrozole or CC for ovulation induction there are few treatment options available to PCOS patients except proceeding to gonadotropin injections or in vitro fertilization both of which are associated with increased cost and risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None