Trial · NCT03559010
A Study of Oral Contraception Under Simulated OTC Conditions
NCT03559010, Phase 3, Terminated, HRA Pharma; results first posted 2022-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Oral Contraception Under Simulated OTC Conditions. Trials, record NCT03559010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03559010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Contraception Under Simulated OTC Conditions
- NCT number
- NCT03559010
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 189 participants, actual
- Lead sponsor
- HRA Pharma
- Conditions
- Contraception
- Interventions
- Norgestrel 0.075 mg tablets
- First posted
- 2018-06-15
- Last updated
- 2022-04-04
- Results first posted
- 2022-04-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Self-selection | Day One | Proportion of self-selection population who make a correct selection decision regarding use of the product Study prematuraly discontinued No Self-selection endpoint calculations were made. |
| Primary | Actual Use: Use of the Study Medication Every Day | Up to 16 weeks | Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made |
| Primary | Actual Use: Use of the Study Medication at the Same Time of Day | Up to 16 weeks | Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made. |
| Primary | Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs | Up to 16 weeks | Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made |
| Secondary | Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control. | Up to 16 weeks | Proportion of user population who do not use study medication together with another form of hormone-containing birth control. Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made |
| Secondary | Actual Use: Proportion of User Population Who Report Using a Barrier Method of Contraception (or Abstaining From Intercourse) for the First 48 Hours After Starting to Use the Study Medication | Up to 16 weeks | Proportion of user population who report using a barrier method of contraception (or abstaining from intercourse) for the first 48 hours after starting to use the study medication Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made |
| Secondary | Proportion of Self-selection Population Taking One of the "Ask a Doctor or Pharmacist Before Use" Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product | Up to 16 weeks | Proportion of self-selection population taking one of the "ask a doctor or pharmacist before use" products who do not select, who select but do not use, or who report contacting a healthcare provider Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made |
| Secondary | Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product. | Up to 16 weeks | Proportion of self-selection population who report having liver problems who either do not select ,who select but do not use, or who report contacting a healthcare provider about use of the product. Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made. |
| Secondary | Proportion of User Population Who Experience One of the "Talk to a Doctor" Conditions Listed Within the "When Using This Product" or "Stop Use and Ask a Doctor" Sections | Up to 16 weeks | Proportion of user population who experience one of the "Talk to a doctor" conditions listed within the "When using this product" or "Stop use and ask a doctor" sections Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made. |
| Secondary | Safety Population: Number of Pregnancies Reported During the Course of the Study | Up to 16 weeks | Number of pregnancies reported during the course of the study Measurement tool: phone interview |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Self-selection | Day One | The clinical trial was terminated before data are collected. No Endpoints calculations were made | ||
| PRIMARY | Actual Use: Use of the Study Medication Every Day | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| PRIMARY | Actual Use: Use of the Study Medication at the Same Time of Day | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| PRIMARY | Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control. | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Actual Use: Proportion of User Population Who Report Using a Barrier Method of Contraception (or Abstaining From Intercourse) for the First 48 Hours After Starting to Use the Study Medication | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Proportion of Self-selection Population Taking One of the Ask a Doctor or Pharmacist Before Use Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product. | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Proportion of User Population Who Experience One of the Talk to a Doctor Conditions Listed Within the When Using This Product or Stop Use and Ask a Doctor Sections | Up to 16 weeks | the clinical trial was terminated before data are collected. No endpoints calculations were made. | ||
| SECONDARY | Safety Population: Number of Pregnancies Reported During the Course of the Study | Up to 16 weeks | Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Population: Number of Pregnancies Reported During the Course of the Study | Use Phase Norgestrel 0.075 mg | 1 | participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Self Selection Population | 189 | |
| Overall Study | Purchaser Population | Self Selection Population | 113 | |
| Overall Study | Use Phase Norgestrel 0.075 mg | Self Selection Population | 109 | |
| Overall Study | COMPLETED | Self Selection Population | 189 | |
| Overall Study | NOT COMPLETED | Self Selection Population | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Headache | Nervous system disorders | Safety Population | 3 | 116 | 3 |
| other | Migraine | Nervous system disorders | Safety Population | 3 | 116 | 3 |
| other | Acne | Skin and subcutaneous tissue disorders | Safety Population | 6 | 116 | 6 |
| other | Menorrhagia | Reproductive system and breast disorders | Safety Population | 8 | 116 | 8 |
| other | Metrorrhagia | Reproductive system and breast disorders | Safety Population | 8 | 116 | 8 |
| serious | Exposure During Pregnancy | Pregnancy, puerperium and perinatal conditions | Safety Population | 1 | 116 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population | 0 | 116 |
| Total, other adverse events | Safety Population | 28 | 116 |
| Total, serious adverse events | Safety Population | 4 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03559010
GET https://conductscience.org/api/trials/v1/NCT03559010/registered