UnderweightPhase 4NCT01388582
The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
A Phase 4 study testing LNG-IUS, Implanon and 30 mcg EE and 150 LNG oral contraceptive (Microvlar) in people with Underweight, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Underweight
- What is being tested?
- LNG-IUS, Implanon and 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women at the day 42th of post-partum fully breastfeeding-
Who cannot join
- baby premature
- diabetes
- blood hypertension
- not breastfeeding or partial breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women
The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.
Read the detailed description
Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. One sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. Additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. Also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.
- Conditions
- Underweight
- Being tested
- LNG-IUS, Implanon, 30 mcg EE and 150 LNG oral contraceptive (Microvlar), TCu380A copper-intrauterine device, TCu380A intrauterine device
- Keywords
- contraceptives, hormonal, breastfeeding, infant weight
- Medical subject headings
- Thinness, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUSDevice
Also called Mirena, Bayer, Brazil
10 women will receive the LNG-IUS during breastfeeding
ImplanonDevice
Also called Implanon, MSD, Brazil
60 mcg/day contraceptive implant
30 mcg EE and 150 LNG oral contraceptive (Microvlar)Drug
Also called Microvlar (Bayer, Brazil)
10 women will receive oral contraceptive during breastfeeding
TCu380A copper-intrauterine deviceDevice
Also called Optima IUD (Injeflex, Brazil)
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
TCu380A intrauterine deviceDevice
Also called Implanon, MSD, Os, The Netherland, Mirena, Bayer Oy, Tuku, Finland, TCu380A copper intrauterine device; Optima, Injeflex, Brazil, Microvlar oral contraceptive, Bayer, São Paulo, Brazil
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Combined oral contraceptive | Active comparator | 10 women will receive COC during breastfeeding Receives: Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar); Device: TCu380A intrauterine device |
| Levonorgestrel intrauterine system | Active comparator | 10 women will receive a LNG-IUS during breastfeeding Receives: Device: LNG-IUS; Device: TCu380A intrauterine device |
| Implanon | Active comparator | 10 women will receive Implanon during breastfeeding Receives: Device: Implanon; Device: TCu380A intrauterine device |
| TCu380A intrauterine device | Active comparator | 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding Receives: Device: TCu380A copper-intrauterine device; Device: TCu380A intrauterine device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of infant weight, height and size of the tibial
The study have the purpose to evaluate the infant weight, height and size of the tibial in infant who breastfeeding on demand exclusively and their mother were either users of a combined oral contraceptive, placebo, etonogestrel-releasing subdermal contraceptive implant or levonorgestrel-releasing intrauterine system. Additionally, pregnancy effectiveness and any adversse event will record in all groups of women.
Measured: women and children will be evaluated at time frame from day 42 through day 64 post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luis Bahamondes, University of Campinas, Brazil
- Investigators
- Luis Bahamondes, MD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388582
- Sponsor's protocol ID
- 06/2011/PC
- Status last verified
- May 2012
- First submitted
- 16 Jun 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhaes A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Aug;100(2):445-50. doi: 10.1016/j.fertnstert.2013.03.039. Epub 2013 Apr 23.
PubMed 23623474
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women
- ClinicalTrials.gov ID
- NCT01388582
- Acronym / sponsor ID
- 06/2011/PC
- Conditions
- Underweight
- Keywords
- contraceptives, hormonal, breastfeeding, infant weight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.
Detailed description
Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. One sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. Additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. Also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined oral contraceptive | Active comparator | Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar), Device: TCu380A intrauterine device10 women will receive COC during breastfeeding |
| Levonorgestrel intrauterine system | Active comparator | Device: LNG-IUS, Device: TCu380A intrauterine device10 women will receive a LNG-IUS during breastfeeding |
| Implanon | Active comparator | Device: Implanon, Device: TCu380A intrauterine device10 women will receive Implanon during breastfeeding |
| TCu380A intrauterine device | Active comparator | Device: TCu380A copper-intrauterine device, Device: TCu380A intrauterine device10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women at the day 42th of post-partum fully breastfeeding-
Key exclusion criteria (4 listed)
- baby premature
- diabetes
- blood hypertension
- not breastfeeding or partial breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNG-IUSAlso: Mirena, Bayer, Brazil10 women will receive the LNG-IUS during breastfeeding | Device | Levonorgestrel intrauterine system |
| ImplanonAlso: Implanon, MSD, Brazil60 mcg/day contraceptive implant | Device | Implanon |
| 30 mcg EE and 150 LNG oral contraceptive (Microvlar)Also: Microvlar (Bayer, Brazil)10 women will receive oral contraceptive during breastfeeding | Drug | Combined oral contraceptive |
| TCu380A copper-intrauterine deviceAlso: Optima IUD (Injeflex, Brazil)Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group | Device | TCu380A intrauterine device |
| TCu380A intrauterine deviceAlso: Implanon, MSD, Os, The Netherland, Mirena, Bayer Oy, Tuku, Finland, TCu380A copper intrauterine device; Optima, Injeflex, Brazil, Microvlar oral contraceptive, Bayer, São Paulo, Brazil10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding | Device | Combined oral contraceptive, Implanon, Levonorgestrel intrauterine system, TCu380A intrauterine device |
Primary outcome
Evaluation of infant weight, height and size of the tibial
Time frame: women and children will be evaluated at time frame from day 42 through day 64 post-partum
The study have the purpose to evaluate the infant weight, height and size of the tibial in infant who breastfeeding on demand exclusively and their mother were either users of a combined oral contraceptive, placebo, etonogestrel-releasing subdermal contraceptive implant or levonorgestrel-releasing intrauterine system. Additionally, pregnancy effectiveness and any adversse event will record in all groups of women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
- Derived from this study: PubMed 23623474Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhaes A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Aug;100(2):445-50. doi: 10.1016/j.fertnstert.2013.03.039. Epub 2013 Apr 23.
Related trials for Underweight
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
Recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
RecruitingPhase 3
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Neurodevelopment Outcome, Linear Growth
Recruiting
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Anorexia Nervosa
Recruiting
Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Young Children
Undernutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Bahamondes, MD principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LNG-IUS, Implanon and 30 mcg EE and 150 LNG oral contraceptive (Microvlar) in people with Underweight, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of infant weight, height and size of the tibial (time frame: women and children will be evaluated at time frame from day 42 through day 64 post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.