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A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Female Infertility

Intervention: Dydrogesterone 30 mg (Drug); intravaginal progesterone gel 90 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Darline Cheatham-Seitz, MD PhD, Study Director, Affiliation: Abbott

Overall contact:
Erik van Leeuwen, MSc, Phone: +31294479241, Email: erik.vanleeuwen@abbott.com

Summary

The purpose of this randomized, two-arm and open label study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who are unable to conceive a child and are undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation. Patients will be followed during treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn (s).

Clinical Details

Official title: A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pregnancy rate

Secondary outcome:

Positive Pregnancy test rate

Rate of successful completion of pregnancy

Adverse Events

physical examination newborn

physical examination newborn

physical examination newborn

physical examination newborn

physical examination newborn

physical examination on hypospadias of the newborns

Eligibility

Minimum age: 19 Years. Maximum age: 41 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Signed informed consent;

- Premenopausal females, age > 18 years < 42 years

- Non-smokers. For females who were past smokers, they must have stopped tobacco usage

for at least 3 months prior baseline visit

- Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone) less than or

equal to 15 IU/L and estradiol (E2)within normal limits

- LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH

(thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior to screening

- Documented history of infertility (e. g., unable to conceive for at least one year or

for 6 months for women ≥ 38 years of age or bilateral tubal occlusion or absence)

- Normal transvaginal ultrasound at screening (or within 14 days of screening) without

evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)

- Negative pregnancy test on the day of pituitary down regulation (prior to

administration of GnRH agonist or GnRH antagonist)

- Clinically indicated protocol for induction of IVF with a fresh embryo

- Single or dual embryo transfer

- BMI ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

- Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,

hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study;

- Acute urogenital disease

- Known allergic reactions to progesterone products

- Known allergic reactions to peanuts and peanut oil

- Intake of experimental drug or participation in any other clinical trial within 30

days prior to study start

- Mental disability or any other lack of fitness, in the Investigator's opinion, to

preclude subjects to participate in or to complete the study

- Current or recent substance abuse, including alcohol and tobacco (Note: Patients who

stopped tobacco usage at least 3 months prior to screening visit would be allowed)

- History of chemotherapy or radiotherapy

- Patients with more than 3 unsuccessful IVF attempts

- Contraindication for pregnancy

- Refusal or inability to comply with the requirements of the study protocol for any

reason, including scheduled clinic visits and laboratory tests

- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages

Acute urogenital disease

Locations and Contacts

Erik van Leeuwen, MSc, Phone: +31294479241, Email: erik.vanleeuwen@abbott.com

The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China; Recruiting
Jiayin Liu, Phone: +8602568302608, Email: jyliu_jn@126.com
Additional Information

Starting date: July 2015
Last updated: August 17, 2015

Page last updated: August 23, 2015

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