Trial · NCT02491437
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)
NCT02491437, Phase 3, Completed, Abbott; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT02491437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02491437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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)
- NCT number
- NCT02491437
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,034 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Female Infertility
- Interventions
- Dydrogesterone 30 mg, intravaginal progesterone gel 90 mg
- First posted
- 2015-07-08
- Last updated
- 2019-10-01
- Other registries' IDs
- eudract:2012-002993-29
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound | 12 weeks´ gestation | Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound. |
| Secondary | Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer) | Day 14 after embryo transfer | Positive biochemical pregnancy test on Day 14 after embryo transfer |
| Secondary | Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth) | After delivery (about 9 months after IVF) | Live birth rate (percentage of participants with a live birth) |
| Secondary | Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | After delivery (about 9 months after IVF) | The gender (number of delivered newborns that are male or female) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound | 12 weeks´ gestation | Full Analysis Sample (FAS) | percentage of participants | NUMBER |
| SECONDARY | Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer) | Day 14 after embryo transfer | Full Analysis Sample (FAS) | percentage of participants | NUMBER |
| SECONDARY | Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth) | After delivery (about 9 months after IVF) | Full Analysis Sample (FAS) | percentage of participants | NUMBER |
| SECONDARY | Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | After delivery (about 9 months after IVF) | Full Analysis Sample (FAS). These are the number of delivered babies from the mothers in the FAS | number of newborns | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound | Dydrogesterone Tablets 3x10 mg | 38.7 | 95% Confidence Interval 34.4 to 43.1 | percentage of participants | |
| Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound | Crinone 8% Intravaginal Progesterone Gel 90 mg | 35.0 | 95% Confidence Interval 30.7 to 39.4 | percentage of participants | |
| Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer) | Dydrogesterone Tablets 3x10 mg | 47.4 | 95% Confidence Interval 42.9 to 51.9 | percentage of participants | |
| Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer) | Crinone 8% Intravaginal Progesterone Gel 90 mg | 43.8 | 95% Confidence Interval 39.3 to 48.3 | percentage of participants | |
| Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth) | Dydrogesterone Tablets 3x10 mg | 34.4 | 95% Confidence Interval 30.2 to 38.8 | percentage of participants | |
| Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth) | Crinone 8% Intravaginal Progesterone Gel 90 mg | 32.5 | 95% Confidence Interval 28.4 to 36.9 | percentage of participants | |
| Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | Dydrogesterone Tablets 3x10 mg | Gender male | 105 | number of newborns | |
| Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | Crinone 8% Intravaginal Progesterone Gel 90 mg | Gender male | 95 | number of newborns | |
| Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | Dydrogesterone Tablets 3x10 mg | Gender female | 100 | number of newborns | |
| Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) | Crinone 8% Intravaginal Progesterone Gel 90 mg | Gender female | 93 | number of newborns |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dydrogesterone Tablets 3x10 mg | 520 | |
| Overall Study | STARTED | Crinone 8% Intravaginal Progesterone Gel 90 mg | 514 | |
| Overall Study | Safety Sample | Dydrogesterone Tablets 3x10 mg | 518 | |
| Overall Study | Safety Sample | Crinone 8% Intravaginal Progesterone Gel 90 mg | 512 | |
| Overall Study | Full Analysis Sample | Dydrogesterone Tablets 3x10 mg | 494 | |
| Overall Study | Full Analysis Sample | Crinone 8% Intravaginal Progesterone Gel 90 mg | 489 | |
| Overall Study | COMPLETED | Dydrogesterone Tablets 3x10 mg | 168 | |
| Overall Study | COMPLETED | Crinone 8% Intravaginal Progesterone Gel 90 mg | 157 | |
| Overall Study | NOT COMPLETED | Dydrogesterone Tablets 3x10 mg | 352 | |
| Overall Study | NOT COMPLETED | Crinone 8% Intravaginal Progesterone Gel 90 mg | 357 |
Source ClinicalTrials.gov
Adverse events256
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vaginal haemorrhage | Pregnancy, puerperium and perinatal conditions | Dydrogesterone Tablets 3x10 mg (Maternal) | 50 | 518 | 50 |
| other | Vaginal haemorrhage | Pregnancy, puerperium and perinatal conditions | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 35 | 512 | 35 |
| other | Vaginal haemorrhage | Pregnancy, puerperium and perinatal conditions | Dydrogesterone Tablets (Fetus/Newborn) | 0 | 0 | 0 |
| other | Vaginal haemorrhage | Pregnancy, puerperium and perinatal conditions | Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) | 0 | 0 | 0 |
| serious | abortions spontaneous (related to the mother) | Pregnancy, puerperium and perinatal conditions | Dydrogesterone Tablets 3x10 mg (Maternal) | 12 | 518 | 12 |
| serious | abortions spontaneous (related to the mother) | Pregnancy, puerperium and perinatal conditions | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 14 | 512 | 14 |
| serious | abortions spontaneous (related to the mother) | Pregnancy, puerperium and perinatal conditions | Dydrogesterone Tablets (Fetus/Newborn) | 0 | 221 | 0 |
| serious | abortions spontaneous (related to the mother) | Pregnancy, puerperium and perinatal conditions | Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) | 0 | 201 | 0 |
| serious | maternal complications of pregnancy (related to the mother) | Pregnancy, puerperium and perinatal conditions | Dydrogesterone Tablets 3x10 mg (Maternal) | 8 | 518 | 8 |
| serious | maternal complications of pregnancy (related to the mother) | Pregnancy, puerperium and perinatal conditions | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 11 | 512 | 11 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dydrogesterone Tablets 3x10 mg (Maternal) | 0 | 518 |
| Total, all-cause mortality | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 0 | 512 |
| Total, all-cause mortality | Dydrogesterone Tablets (Fetus/Newborn) | 4 | 221 |
| Total, all-cause mortality | Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) | 0 | 201 |
| Total, other adverse events | Dydrogesterone Tablets 3x10 mg (Maternal) | 50 | 518 |
| Total, other adverse events | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 35 | 512 |
| Total, other adverse events | Dydrogesterone Tablets (Fetus/Newborn) | 0 | 0 |
| Total, other adverse events | Crinone 8% Intravaginal Progesterone Gel (Fetus/Newborn) | 0 | 0 |
| Total, serious adverse events | Dydrogesterone Tablets 3x10 mg (Maternal) | 71 | 518 |
| Total, serious adverse events | Crinone 8% Intravaginal Progesterone Gel 90 mg (Maternal) | 67 | 512 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30304457 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02491437
GET https://conductscience.org/api/trials/v1/NCT02491437/events?page=2