Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

About 66 Patients took Letrozole drug only for induction of ovulation at the time of suspected ovulation maturity.

About 66 Patients took Letrozole drug in addition to HCG for induction of ovulation at the time of suspected ovulation maturity.

To determine if the usage of All interventions are effective for simple induction of ovulation in polycystic ovarian syndrome in infertile couples.

Letrozole tablets

Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.

Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure

The first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome (PCOS) patients was done in 2000.

In large randomized study, letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome. Letrozole was also associated with higher live-birth and ovulation rates.

Ovulation induction with letrozole is associated with an ovulation rate of 70%-84% and a pregnancy rate of 20%-27% per cycle.

While in another study which Compare the Effect of Letrozole Alone with Letrozole Plus N-Acetylcysteine on Pregnancy Rate in Patients with Polycystic Ovarian Syndrome, the pregnancy rate was 7.5% in letrozole alone group .

Human chorionic gonadotropin (HCG) hormone will replace the naturally surging luteinizing hormone at mid-cycle, subsequently, will lead to full maturation of oocytes resulting in ovulation. Additionally, HCG will also enhance the endometrial quality by stimulating the corpus luteum. HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells, it is also produced by other organs in minute amounts (Liver, colon and pituitary gland). HCG main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone.

This hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols.

In order to diagnose Polycystic ovarian syndrome two out of three Rotterdam criteria should be present. These criteria are: chronic anovulation, clinical and/or biochemical evidence of hyperandrogenism, and polycystic ovaries by ultrasound .

incidence of PCOS from 6% to 21% when the ESHRE/ASRM 2003 criteria were applied. Infertility (clinical definition) is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles

Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol

The Effect of Using Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol on Induction of Ovulation in Polycystic Ovarian Syndrome Patients: A Prospective Cohort Study

The participants required to make pregnancy test after taking the drugs of the study

Egymedicalpedia

Rare Diseases

Gestational Trophoblastic Disease

Hydatidiform Mole

Nevus

Trophoblastic Neoplasms

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications, Neoplastic

Gestational Trophoblastic Tumor

Vasodilator Agents

Nitroglycerin

Patients with complete mole treated by evacuation of using suction curettage followed by conservative follow up

Patients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up

both groups underwent complete mole evacuation using suction curettage.

Suction evacuation

Group II Patients received 5mg(2tablets 2.5gm) daily letrozole for 10 days after complete mole evacuation

Mohamed A Alabiad, MD

Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)

Management of hydatidiform mole is usually evacuation followed by β-hcg surveillance to early detect cases of GTN . The risk of developing GTN is reported to be 16% to 20% in women with CHM . GTN is a potentially life-threatening malignancy but has an excellent cure rate. Trials were conducted to assess the role of prophylactic chemotherapy to prevent the development of GTN. In addition to their side effects, a meta-analysis concluded that there is insufficient evidence to support the use of prophylactic chemotherapy in clinical practice. Third-generation aromatase inhibitors such as letrozole have been shown to successfully block estrogen production in women of reproductive age. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use and recently used successfully alone in the medical treatment of ectopic pregnancy making marked degenerative effects on the placenta.

The study hypothesizes that by inhibiting the estrogen synthetase (the aromatase enzyme) progesterone would not exert its physiological role in maintaining early pregnancy including complete hydatidiform mole. Thus, using a prophylactic aromatase inhibitor after CHM may have a role in the prevention of GTN and more effective clearance of β-hcg.

Rational GTN is a potentially life-threatening malignancy. The risk of progression of CHM to GTN is 20%. Prophylactic use of aromatase inhibitor may decrease the incidence of GTN.

Research question:

Is prophylactic use of aromatase inhibitor effective in decreasing the incidence of GTN in patients with CHM

Hypothesis Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM

Aim of this work The study aims at figuring out whether prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM.

OBJECTIVES

* To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
* To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
* To assess the side effects of aromatase inhibitor when used as a prophylaxis against GTN development in CHM cases.

PATIENTS AND METHODS

Technical design:

* Setting: Department of Obstetrics and Gynecology
* Sample size: 200 patients diagnosed to have CHM by ultrasound and confirmed by histopathological examination.

Operational design:

* Type of the study: a randomized controlled trial.
* Steps of performance and techniques that will be used

women included in the study will be subjected to the following

Preoperative

1. Complete history taking.
2. General and abdominal examination.
3. Routine preoperative laboratory investigations.
4. Ultrasound to diagnose complete hydatidiform mole.
5. Measurement of β-hcg level. Intraoperative

   * Evacuation of CHM using Suction curettage.
   * Tissues obtained during an evacuation will be sent for histological assessment. Post-operative
   * Women will be randomized classified into two groups
   * Control group I: Conservative follow up
   * Prophylactic letrozole group II 5-mg Letrozole will be administered as two 2.5-mg tablets every day for 10 days.
   * All Patients will receive instruction to return for β-hcg follow up which will be done weekly till complete resolution then monthly for 6 months.
   * Participants will be advised to receive contraception during the follow-up period.
   * The patients who will develop GTN in either group will be picked up and the incidence of GTN will be calculated in each group.

Letrozole as a Prophylaxis From GTN for Complete Mole Patients

The Prophylactic Role of Aromatase Inhibitor Letrozole in Decreasing the Incidence of Gestational Trophoblastic Neoplasia in Patients With Complete Hydatidiform Mole

A quantitative human chorionic gonadotropin

Zagazig University

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Pharmaceutical Solutions

Reproductive Control Agents

Tamoxifen

Exemestane

Leuprolide

Anastrozole

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months

TOL2506

20 mg once daily or 10 mg 2 times daily - either tablet of solution

One 2.5 mg tablet taken orally once daily

Anastrozole Tablets

Exemestane Tablets

TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

Tolmar Inc.

Mitogens

TOL2506 in combinatination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months.

20 mg once daily or 10 mg 2 times daily - either tablet or solution

Letrozole Tablets

A Mehta

C Fajardo

E P Hamilton

This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess the safety of TOL2506 in men with HR+, HER2-negative breast cancer. The Screening Period will be conducted in two parts: 1) an abbreviated, initial screening where premenopausal status will be determined prior to neoadjuvant or adjuvant chemotherapy (if planned) and 2) the full screening assessment conducted after neoadjuvant or adjuvant chemotherapy (or for subjects who enter the study without having received chemotherapy). Following the Screening Period, eligible subjects will enter into the 48 week Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of \< 20 pg/mL (testosterone levels \< 50 ng/dL in males) have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit (eg, Week 24, 36, and 48 where a pre-dose blood sample for PK and PD analysis will be drawn). At the end of the Treatment Period, upon completion of the End of Study Visit (Visit 9, Week 48) subjects may be eligible to participate in a Safety Extension Study under a separate Protocol.

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + endocrine therapy (tamoxifen or aromatase inhibitors) at every measurement from Week 6 to Week 48

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + tamoxifen at every measurement from Week 6 to Week 48

Percent of all subjects with LH \< 4 IU/L, E2 \<20 pg/mL in subjects treated with TOL2506 + aromatase inhibitor at every measurement from Week 6 to Week 48

Fulvestrant

BEBT-209 capsules, 25mg once daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 25mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 50mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 150mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.

BEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.

BEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle

BEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle

BEBT-209 capsules, 25mg once daily, or 25mg, 50mg, 75mg, 100mg, 150mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

BEBT-209 capsules

Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.

Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle

Quchang Ouyang, Phd

Shouman Wang, Phd

This clinical study includes a dose escalation trial of BEBT-209 monotherapy in HR +/HER2- advanced breast cancer patients and a Phase 1b trial of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant in ER +/HER2- advanced breast cancer in women. To evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant. To determine the recommended dose for late clinical studies of monotherapy or combination therapy in patients with HR +/HER2- advanced breast cancer.

* Dose escalation phase: To conduct approximately 6 dose levels, with a starting dose of 25 mg/day of BEBT-209, and subsequent dose groups were first dose escalated at 100%, with dose escalation at 50% for subsequent dose groups if one drug-related Grade 2 nonhematologic or Grade 3 hematologic toxicity was identified and dose-limiting toxicity was not reached. If one dose limiting toxicity was identified and the maximum tolerated dose was not reached, dose escalation was performed at 33% for the subsequent dose groups.
* Phase Ib of BEBT-209 as single therapy, in Combination with Letrozole, in Combination with Fulvestrant: According to the pharmacokinetics, safety and preliminary efficacy of BEBT-209 in the dose escalation phase, one dose was selected for the BEBT-209 monotherapy group, two doses were selected for the combination with letrozole group, and two doses were selected for the combination with fulvestrant group, and all five groups were continuously administered until disease progression or unacceptable toxicity or patient withdrawal or death. Late phase clinical trials were conducted as appropriate based on preliminary safety tolerability, pharmacokinetics, and preliminary efficacy results from Phase 1b.

Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance.

Dose escalation phase: 6 dose levels are carried out, the starting dose of BEBT-209 is set to 25mg/day, and the accelerated titration method combined with the "3+3" mode is used for climbing research.

Phase Ib: According to the pharmacokinetics, safety and preliminary efficacy of BEBT-209 in the dose escalation phase, one dose was selected for the BEBT-209 monotherapy group, two doses were selected for the combination with letrozole group, and two doses were selected for the combination with fulvestrant group, and all five groups were continuously administered until disease progression or unacceptable toxicity or patient withdrawal or death.

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer

A Phase I, Open, Multicenter Study of BEBT-209 in Women With Advanced Breast Cancer

Area under the blood concentration time curve from 0 to 48 hours after administration

Area under the blood concentration time curve from time zero to the last dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol	NCT06367712	PCOS (Polycysti...	Letrozole table...	18 Years - 35 Years	Egymedicalpedia
Letrozole as a Prophylaxis From GTN for Complete Mole Patients	NCT05203562	Gestational Tro...	Suction evacuat... Letrozole table...	20 Years - 40 Years	Zagazig University
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study	NCT05645536	Breast Cancer	TOL2506 Tamoxifen Letrozole table... Anastrozole Tab... Exemestane Tabl...	18 Years - 51 Years	Tolmar Inc.
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer	NCT04906395	Breast Cancer	TOL2506 Tamoxifen Letrozole Table... Anastrozole Tab... Exemestane Tabl...	18 Years - 49 Years	Tolmar Inc.
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study	NCT05645536	Breast Cancer	TOL2506 Tamoxifen Letrozole table... Anastrozole Tab... Exemestane Tabl...	18 Years - 51 Years	Tolmar Inc.
Letrozole as a Prophylaxis From GTN for Complete Mole Patients	NCT05203562	Gestational Tro...	Suction evacuat... Letrozole table...	20 Years - 40 Years	Zagazig University
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer	NCT04906395	Breast Cancer	TOL2506 Tamoxifen Letrozole Table... Anastrozole Tab... Exemestane Tabl...	18 Years - 49 Years	Tolmar Inc.
Phase I Study of BEBT-209 in Women With Advanced Breast Cancer	NCT06047184	Advanced Breast...	BEBT-209 capsul... Letrozole table... Fulvestrant	18 Years -	BeBetter Med Inc

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