Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

December 1, 2016 updated by: Bayer

Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Drop out-rate will be covered in Participant flow section.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2885

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Lanus Oeste, Buenos Aires, Argentina, 1824
      • San Isidro, Buenos Aires, Argentina, B1642CLN
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425ASQ
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
  • Canada
      • Quebec, Canada, G1V 4X7
      • Quebec, Canada, G1S 2L6
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
      • Winnipeg, Manitoba, Canada, R3E 3P4
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N6A 4G5
      • Waterloo, Ontario, Canada, N2L 6H6
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
      • Montreal, Quebec, Canada, H1T 1P6
      • Shawinigan, Quebec, Canada, G9N 2H6
      • Sherbrooke, Quebec, Canada, J1H 4J6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
  • Chile
      • Santiago, Chile
      • Santiago de Chile, Chile
  • Finland
      • Espoo, Finland, 02100
      • Helsinki, Finland, 00260
      • Helsinki, Finland, 00100
      • Joensuu, Finland, 80100
      • Kotka, Finland, 48100
      • Kuopio, Finland, 70110
      • Lahti, Finland, 15110
      • Oulu, Finland, 90100
      • Oulu, Finland, 90220
      • Oulu, Finland, 90570
      • Tampere, Finland, 33100
      • Turku, Finland, 20520
      • Turku, Finland, 20100
      • Turku, Finland, 20540
  • France
      • COMPIEGNE cedex, France, 60204
      • Grenoble, France, 38043
      • Le Chesnay, France, 78150
      • Lille, France, 59037
      • Nimes, France, 30029
      • Quetigny, France, 21800
      • REIMS Cedex, France, 51092
      • Roanne, France, 42300
  • Hungary
      • Bekescsaba, Hungary, 5600
      • Budapest, Hungary, 1116
      • Eger, Hungary, 3300
      • Esztergom, Hungary, 2500
      • Kecskemet, Hungary, 6000
      • Nyiregyhaza, Hungary, 4400
      • Szentes, Hungary, 6600
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
  • Mexico
      • México, D.F., Mexico, 11000
      • México, D.F., Mexico, 06720
    • Coahuila
      • Torreón, Coahuila, Mexico, 27000
    • Distrito Federal
      • México, D.F., Distrito Federal, Mexico, 06700
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
    • Sonora
      • Hermosillo, Sonora, Mexico, 83100
  • Netherlands
      • Alkmaar, Netherlands, 1817 MS
      • Den Haag, Netherlands, 2545 CH
      • Eindhoven, Netherlands, 5623 EJ
      • Heerlen, Netherlands, 6419 PC
      • Helmond, Netherlands, 5707 HA
      • Hoofddorp, Netherlands, 2134 TM
      • Nijmegen, Netherlands, 6532 SZ
      • Rotterdam, Netherlands, 3079 DZ
      • Utrecht, Netherlands, 3582 KE
  • Norway
      • Elverum, Norway, 2403
      • Kolbotn, Norway, 1411
      • Larvik, Norway, 3264
      • Oslo, Norway, 0364
      • Trondheim, Norway, 7014
  • Sweden
      • Göteborg, Sweden, 416 64
      • Luleå, Sweden, 972 33
      • Malmö, Sweden, 217 44
      • Norrköping, Sweden, 602 22
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 141 86
      • Stockholm, Sweden, 182 88
      • Stockholm, Sweden, 118 83
      • Umeå, Sweden, 90185
      • Uppsala, Sweden, 75185
      • Örebro, Sweden, 70185
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Glendale, Arizona, United States, 85304
      • Phoenix, Arizona, United States, 85032
      • Tucson, Arizona, United States, 85712
    • California
      • Carmichael, California, United States, 95608
      • Pacific Palisades, California, United States, 90272
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92130
      • Torrance, California, United States, 90502
    • Colorado
      • Denver, Colorado, United States, 80218
      • Littleton, Colorado, United States, 80128
    • Florida
      • Boyton Beach, Florida, United States, 33472
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33186
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Decatur, Georgia, United States, 30034
    • Idaho
      • Boise, Idaho, United States, 83702
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Evansville, Indiana, United States, 47714
      • South Bend, Indiana, United States, 46601
    • Louisiana
      • Marrero, Louisiana, United States, 70072
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States, 89135
      • Las Vegas, Nevada, United States, 89128
      • Las Vegas, Nevada, United States, 89106
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
      • New Brunswick, New Jersey, United States, 08903-2685
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • New Bern, North Carolina, United States, 28562
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Columbus, Ohio, United States, 43213
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
      • Pittsburgh, Pennsylvania, United States, 15213-3180
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Memphis, Tennessee, United States, 38119
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78748
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77054
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
  • Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

  • Known or suspected pregnancy or is lactating.
  • History of ectopic pregnancies.
  • Any genital infection (until successfully treated).
  • Abnormal uterine bleeding of unknown origin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Drug: LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
Experimental: LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Drug: LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pearl Index up to 3 Years
Time Frame: Up to 3 years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
Up to 3 years
Pearl Index for LCS16 up to 5 Years
Time Frame: Up to 5 years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Time Frame: Day 1 to Day 90
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 1 to Day 90
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Time Frame: Day 91 to Day 180
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 91 to Day 180
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Time Frame: Day 181 to Day 270
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 181 to Day 270
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Time Frame: Day 271 to Day 360
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 271 to Day 360
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Time Frame: Day 991 to Day 1080
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 991 to Day 1080
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Time Frame: Day 1 to Day 30
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 1 to Day 30
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Time Frame: Day 31 to Day 60
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 31 to Day 60
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Time Frame: Day 61 to Day 90
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 61 to Day 90
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Time Frame: Day 91 to Day 120
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 91 to Day 120
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Time Frame: Day 331 to Day 360
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 331 to Day 360
Number of Participants With/Without Ovulation - Year 1
Time Frame: For six weeks in the second half of Year 1
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
For six weeks in the second half of Year 1
Number of Participants With/Without Ovulation - Year 2
Time Frame: For six weeks in the second half of Year 2
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
For six weeks in the second half of Year 2
Number of Participants With/Without Ovulation - Year 3
Time Frame: For six weeks in the second half of Year 3
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
For six weeks in the second half of Year 3
Average Total Cervical Score - Year 1
Time Frame: For six weeks in the second half of Year 1
Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
For six weeks in the second half of Year 1
Average Total Cervical Score - Year 2
Time Frame: For six weeks in the second half of Year 2

Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.

Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
For six weeks in the second half of Year 2
Average Total Cervical Score - Year 3
Time Frame: For six weeks in the second half of Year 3
Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
For six weeks in the second half of Year 3
Classification of Endometrium - Year 1
Time Frame: At Year 1
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
At Year 1
Classification of Endometrium - Year 2
Time Frame: At Year 2
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
At Year 2
Classification of Endometrium - Year 3 / End of Study
Time Frame: At Year 3 / End of study
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
At Year 3 / End of study
Degree of User Overall Satisfaction With Study Treatment
Time Frame: At the end of study/Year 3
Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
At the end of study/Year 3
Number of Participants With Partial or Total Expulsion
Time Frame: Up to 3 years
If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
Up to 3 years
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Time Frame: Day 1081 to Day 1170
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 1081 to Day 1170
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Time Frame: Day 1711 to Day 1800
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Day 1711 to Day 1800
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Time Frame: At the end of study/Year 5
Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
At the end of study/Year 5
Number of Participants With Partial or Total Expulsion up to 5 Years
Time Frame: Up to 5 years
If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91665
  • 310442 (Other Identifier: Company internal)
  • G04209F (Other Identifier: Company internal)
  • G04209G (Other Identifier: Company internal)
  • 2007-000420-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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