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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02491437




Registration number
NCT02491437
Ethics application status
Date submitted
16/06/2015
Date registered
8/07/2015
Date last updated
1/10/2019

Titles & IDs
Public title
A 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)
Scientific 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)
Secondary ID [1] 0 0
2012-002993-29
Secondary ID [2] 0 0
M13-625
Universal Trial Number (UTN)
Trial acronym
LOTUS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Infertility 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dydrogesterone 30 mg
Treatment: Drugs - intravaginal progesterone gel 90 mg

Experimental: Dydrogesterone tablets 3x10 mg - Dydrogesterone tablets 3x10 mg

Experimental: Crinone 8% intravaginal progesterone gel 90 mg - Crinone 8% intravaginal progesterone gel 90 mg


Treatment: Drugs: Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid

Treatment: Drugs: intravaginal progesterone gel 90 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound
Timepoint [1] 0 0
12 weeks´ gestation
Secondary outcome [1] 0 0
Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer)
Timepoint [1] 0 0
Day 14 after embryo transfer
Secondary outcome [2] 0 0
Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth)
Timepoint [2] 0 0
After delivery (about 9 months after IVF)
Secondary outcome [3] 0 0
Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female)
Timepoint [3] 0 0
After delivery (about 9 months after IVF)

Eligibility
Key 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 screening visit

- Early follicular phase (Day 2-4) Follicle stimulating hormone (FSH) less than or equal
to 15 IU/L and estradiol (E2)within normal limits at screening

- luteinizing hormone (LH), prolactin (PRL), T (testosterone) and thyroid-stimulating
hormone (TSH), within the normal limits for the clinical laboratory, or considered not
clinically significant by the Investigator within 6 months prior or at 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 prior of screening)
without evidence of clinically significant abnormality consistent with finding
adequate for Assisted Reproductive Technology (ART) with respect to uterus and adnexa
(no hydrosalpinx or clinically relevant uterine fibroids)

- Subject is not pregnant , confirmed by negative pregnancy or by Investigator Judgement

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

- Single or dual embryo transfer

- BMI = 18 and = 30 kg/m2
Minimum age
19 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 àny experimental drug or any 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
1034
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne IVF - East Melbourne
Recruitment hospital [2] 0 0
IVF Australia - St George Private HospitalIVF Australia - St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Jette
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Changsha
Country [6] 0 0
China
State/province [6] 0 0
Chengdu
Country [7] 0 0
China
State/province [7] 0 0
Guangzhou
Country [8] 0 0
China
State/province [8] 0 0
Hefei
Country [9] 0 0
China
State/province [9] 0 0
Nanjing
Country [10] 0 0
China
State/province [10] 0 0
Wuhan
Country [11] 0 0
China
State/province [11] 0 0
Zhengzhou
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bielefeld
Country [14] 0 0
Germany
State/province [14] 0 0
Dortmund
Country [15] 0 0
Germany
State/province [15] 0 0
Lübeck
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Hong Kong
Country [17] 0 0
India
State/province [17] 0 0
Aurangabad
Country [18] 0 0
India
State/province [18] 0 0
Bangalore
Country [19] 0 0
India
State/province [19] 0 0
Delhi
Country [20] 0 0
India
State/province [20] 0 0
Kolkata
Country [21] 0 0
India
State/province [21] 0 0
Lucknow
Country [22] 0 0
India
State/province [22] 0 0
Pune
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Ekaterinburg
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Saint-Petersburg
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Thailand
State/province [27] 0 0
Bangkok
Country [28] 0 0
Thailand
State/province [28] 0 0
Chiang Mai
Country [29] 0 0
Ukraine
State/province [29] 0 0
Chernivtsi
Country [30] 0 0
Ukraine
State/province [30] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Datamap
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02491437
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shreyansh Shah, MD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries