Trial Outcomes & Findings for Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS) (NCT NCT00805935)
NCT ID: NCT00805935
Last Updated: 2012-01-27
Results Overview
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
weeks 1-3
Results posted on
2012-01-27
Participant Flow
The original plan was for 200 participants to be enrolled across six (6) women's reproductive study centers across the US.
127 patients were screened. 120 patients were randomized. Of the randomized patients, 10 did not receive treatment. 110 randomized participants started the study on treatment.
Participant milestones
| Measure |
Menotropin/Progesterone Vaginal Insert
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
28
|
30
|
|
Overall Study
COMPLETED
|
12
|
8
|
13
|
19
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
15
|
11
|
Reasons for withdrawal
| Measure |
Menotropin/Progesterone Vaginal Insert
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Overall Study
Stimulation Failure
|
1
|
5
|
2
|
2
|
|
Overall Study
Cycle cancelled
|
0
|
0
|
2
|
0
|
|
Overall Study
Cycle cancellation for risk of OHSS
|
1
|
0
|
1
|
0
|
|
Overall Study
Ovarian hyperstimulation syndrome(OHSS)
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
No positive serum pregnancy
|
8
|
7
|
6
|
5
|
|
Overall Study
Pregnancy not confirmed by ultrasound
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy loss/miscarriage
|
2
|
0
|
0
|
0
|
|
Overall Study
Biochemical pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Chemical pregnancy
|
0
|
5
|
3
|
2
|
|
Overall Study
Ectopic pregnancy
|
0
|
0
|
1
|
0
|
|
Overall Study
Serious Adverse Event-congenital anomaly
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: weeks 1-3Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
No
|
24 Participants
|
27 Participants
|
27 Participants
|
30 Participants
|
|
Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: approximately day 15Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=52 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=58 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Number of Follicles Observed at Day 15
|
27.7 Follicles
Standard Deviation 12.8
|
30.5 Follicles
Standard Deviation 16.1
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately day 18Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=52 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=58 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Number of Oocytes Retrieved at Day 18
|
13.0 Oocytes
Standard Deviation 7.7
|
15.6 Oocytes
Standard Deviation 8.6
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately day 19Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=52 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=58 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved
|
17.1 Percentage of oocytes retrieved
|
24.8 Percentage of oocytes retrieved
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately day 24Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells. Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=52 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=58 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Number of Embryos Transferred at Three Stages of Development Before Implantation
Number of embryos transferred
|
2.0 Embryos
Standard Deviation 0.7
|
2.0 Embryos
Standard Deviation 0.5
|
—
|
—
|
|
Number of Embryos Transferred at Three Stages of Development Before Implantation
Number of morula transferred
|
0.0 Embryos
Standard Deviation 0.1
|
0.1 Embryos
Standard Deviation 0.4
|
—
|
—
|
|
Number of Embryos Transferred at Three Stages of Development Before Implantation
Number of blastocyst transferred
|
0.8 Embryos
Standard Deviation 0.9
|
1.1 Embryos
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately day 24Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
The number of embryos that were not transferred but instead were frozen for future use.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=52 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=58 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Number of Embryos Frozen
|
1.9 Embryos
Standard Deviation 2.3
|
1.9 Embryos
Standard Deviation 2.6
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately day 38 (Day 14 post embryo transfer)Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Percentage of Participants With Biochemical Pregnancy at Approximately Day 38
|
60.0 Percentage of participants
|
55.6 Percentage of participants
|
60.7 Percentage of participants
|
73.3 Percentage of participants
|
SECONDARY outcome
Timeframe: approximately Day 52Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinical Pregnancy at Week 7
|
56.0 Percentage of participants
|
33.3 Percentage of participants
|
46.4 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: approximately Day 65Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Percentage of Participants With Ongoing Pregnancy at Week 9
|
48.0 Percentage of participants
|
33.3 Percentage of participants
|
46.4 Percentage of participants
|
63.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 6Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Estradiol Levels at Day 6
|
354.6 pg/mL
Standard Deviation 331.3
|
268.2 pg/mL
Standard Deviation 260.7
|
617.5 pg/mL
Standard Deviation 409.6
|
550.5 pg/mL
Standard Deviation 486.9
|
SECONDARY outcome
Timeframe: Day 6Population: Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication
Blood tests were sent to a central laboratory to obtain hCG levels.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Human Chorionic Gonadotropin (hCG) Levels at Day 6
|
1.0 mIU/ml
Standard Deviation 0.2
|
1.0 mIU/ml
Standard Deviation 0.0
|
1.0 mIU/ml
Standard Deviation 0.0
|
1.0 mIU/ml
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: approximately day 16Blood tests were sent to a central laboratory to obtain progesterone levels.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=23 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=21 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=23 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration
|
1.3 ng/mL
Standard Deviation 0.7
|
1.1 ng/mL
Standard Deviation 0.4
|
1.7 ng/mL
Standard Deviation 0.9
|
1.3 ng/mL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Approximately 10 monthsPopulation: Database was locked prior to most participants giving birth.
Number of live births resulting from the IVF process
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 to week12Population: Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
Outcome measures
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 Participants
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 Participants
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Participants With Treatment Emergent Adverse Events
With at least one adverse event
|
9 Participants
|
12 Participants
|
15 Participants
|
14 Participants
|
|
Participants With Treatment Emergent Adverse Events
With at least one mild or moderate adverse event
|
9 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
|
Participants With Treatment Emergent Adverse Events
With at least one severe adverse event
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events
With at least one serious adverse event
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events
With at least one unrelated or unlikely AE
|
8 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
|
Participants With Treatment Emergent Adverse Events
With at least one possibly or probably related AE
|
3 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
Adverse Events
Menotropin/Progesterone Vaginal Insert
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Menotropin/Progesterone in Oil
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Follitropin Beta/Progesterone Vaginal Insert
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Follitropin Beta/Progesterone in Oil
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 participants at risk
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 participants at risk
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 participants at risk
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 participants at risk
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Conjoined Twins
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
Other adverse events
| Measure |
Menotropin/Progesterone Vaginal Insert
n=25 participants at risk
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Menotropin/Progesterone in Oil
n=27 participants at risk
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone Vaginal Insert
n=28 participants at risk
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
Follitropin Beta/Progesterone in Oil
n=30 participants at risk
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
10.0%
3/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.0%
4/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
18.5%
5/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
21.4%
6/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
13.3%
4/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
General disorders
Injection site anaesthesia
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
General disorders
Oedema Peripheral
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
General disorders
Suprapubic pain
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
6.7%
2/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
10.0%
3/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
6.7%
2/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum Haemorrhage
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
6.7%
2/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Reproductive system and breast disorders
Pelvic Discomfort
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Reproductive system and breast disorders
Uterine Spasm
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.3%
1/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
|
Skin and subcutaneous tissue disorders
Hot flush
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
0.00%
0/30 • Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER