Trial · NCT01181479
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
NCT01181479, Phase 3, Completed, Agile Therapeutics; results first posted 2018-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System. Trials, record NCT01181479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01181479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
- NCT number
- NCT01181479
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,504 participants, actual
- Lead sponsor
- Agile Therapeutics
- Conditions
- Contraception
- Interventions
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- First posted
- 2010-08-13
- Last updated
- 2018-07-03
- Results first posted
- 2018-07-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pregnancy | AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year | Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use. |
| Other | Cycle Control | 6 months | Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS. |
| Other | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months | Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13. |
| Other | Self-reported Irritation at Application Site | 1 year | Evaluation of irritation at application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe |
| Other | Patch Adhesion by Investigator Evaluation at Each Visit | 1 year | Evaluation of patch adhesion was determined using the following scores: 0: \>= 90% adhered (no lift) 1. \>= 75% adhered but \< 90% (some edges showing lift) 2. \>= 50% adhered but \< 75% (half of system lifts off) 3. \< 50% (\> half of system lifts off, but undetached) 4. patch completely detached |
| Other | Self-reported Itching at Patch Application Site | 1 year | Evaluation of itching at patch application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pregnancy | AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year | Subjects in the Safety population, age 17-35 with a BMI \<32, were analyzed. | Pearl Index | NUMBER |
| OTHER_PRE_SPECIFIED | Cycle Control | 6 months | Number of subjects with documented cycle information. | percentage of cycles with BTB/BTS | NUMBER |
| OTHER_PRE_SPECIFIED | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months | Subjects that received contraceptive and were analyzed for LNG and EE. | pg/ml | MEAN |
| OTHER_PRE_SPECIFIED | Self-reported Irritation at Application Site | 1 year | Safety Population | Score on scale | MEAN |
| OTHER_PRE_SPECIFIED | Patch Adhesion by Investigator Evaluation at Each Visit | 1 year | Safety Population | Score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Self-reported Itching at Patch Application Site | 1 year | Safety Population | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pregnancy | AG200-15 for Cycle 7-13 | 5.41 | 95% Confidence Interval 2.35 to 8.46 | Pearl Index | |
| Pregnancy | Lessina | 6.67 | 95% Confidence Interval 0.84 to 12.5 | Pearl Index | |
| Pregnancy | AG200-15 for Cycle 1-13 | 6.43 | 95% Confidence Interval 4.13 to 8.72 | Pearl Index | |
| Cycle Control | AG200-15 for Cycle 1-6 | 23.9 | percentage of cycles with BTB/BTS | ||
| Cycle Control | Lessina | 21.2 | percentage of cycles with BTB/BTS | ||
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Lessina Cycles 1-6 | EE for cycle 2 | 35.4 | 95% Confidence Interval 31.9 to 38.8 | pg/ml |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | AG200-15 for Cycle 1-13 | EE for cycle 2 | 30.5 | 95% Confidence Interval 29.0 to 32.1 | pg/ml |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | AG200-15 for Cycles 7-13 | EE for cycle 2 | NA | 95% Confidence Interval NA to NA | pg/ml |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Lessina Cycles 1-6 | EE cycle 6 | 40.1 | 95% Confidence Interval 33.3 to 46.9 | pg/ml |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | AG200-15 for Cycle 1-13 | EE cycle 6 | 36.7 | 95% Confidence Interval 34.3 to 39.0 | pg/ml |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Subjects Receive AG200-15 or Lessina | STARTED | AG200-15 (Cycles 1-13) | 1,129 | |
| Subjects Receive AG200-15 or Lessina | STARTED | Lessina (Cycles 1-6) | 375 | |
| Subjects Receive AG200-15 or Lessina | STARTED | Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13) | 0 | |
| Subjects Receive AG200-15 or Lessina | COMPLETED | AG200-15 (Cycles 1-13) | 485 | |
| Subjects Receive AG200-15 or Lessina | COMPLETED | Lessina (Cycles 1-6) | 249 | |
| Subjects Receive AG200-15 or Lessina | COMPLETED | Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13) | 0 | |
| Subjects Receive AG200-15 or Lessina | NOT COMPLETED | AG200-15 (Cycles 1-13) | 644 | |
| Subjects Receive AG200-15 or Lessina | NOT COMPLETED | Lessina (Cycles 1-6) | 126 | |
| Subjects Receive AG200-15 or Lessina | NOT COMPLETED | Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13) | 0 | |
| Crossover Subjects Recieve AG200-15 | STARTED | AG200-15 (Cycles 1-13) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
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 | Nasopharyngitis | Infections and infestations | All AG200-15 | 74 | 1,273 | 74 |
| other | Nasopharyngitis | Infections and infestations | Lessina | 12 | 344 | 12 |
| other | Sinusitis | Infections and infestations | All AG200-15 | 45 | 1,273 | 45 |
| other | Sinusitis | Infections and infestations | Lessina | 9 | 344 | 9 |
| other | Upper respiratory tract infection | Infections and infestations | All AG200-15 | 51 | 1,273 | 51 |
| other | Upper respiratory tract infection | Infections and infestations | Lessina | 7 | 344 | 7 |
| other | Urinary tract infection | Infections and infestations | All AG200-15 | 44 | 1,273 | 44 |
| other | Urinary tract infection | Infections and infestations | Lessina | 11 | 344 | 11 |
| other | Cervical Dysplasia | Reproductive system and breast disorders | All AG200-15 | 80 | 1,273 | 80 |
| other | Cervical Dysplasia | Reproductive system and breast disorders | Lessina | 17 | 344 | 17 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All AG200-15 | 0 | 1,273 |
| Total, all-cause mortality | Lessina | 1 | 344 |
| Total, other adverse events | All AG200-15 | 484 | 1,273 |
| Total, other adverse events | Lessina | 112 | 344 |
| Total, serious adverse events | All AG200-15 | 14 | 1,273 |
| Total, serious adverse events | Lessina | 4 | 344 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| All AG200-15 vs Lessina: deaths from any cause | Trial comparisons |
| All AG200-15 vs Lessina: serious adverse events | Trial comparisons |
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/NCT01181479
GET https://conductscience.org/api/trials/v1/NCT01181479/results?page=2